Summary:
Our client, a global pharmaceutical company based in Cork is looking to hire an Associate Director of Manufacturing Engineering. The successful candidate will be responsible for the leadership and management of the site maintenance team ensuring the availability of plant and services across both tablet manufacturing & packaging. Task management of employees and personnel management, including tactical career development coaching. Leads the day-to-day activities of a large team of Engineers & Technicians across the Engineering Operations group including Manufacturing, Packaging, Facilities & Utilities.
Responsibilities:

• Builds and manages an effective team and ensures that all personnel are fully aligned to the Engineering Vision & strategy, their customer needs and requirements, providing an excellent level of services.
• Management of the facilities and maintenance operations in the Dublin Distribution Centre which will require an extensive understanding and application of principles, concepts, practices and standards in engineering.
• Ensures team follows the highest standard of compliance with all EHS and Quality standards.
• Manages maintenance operations and services including equipment installations, service contracts and new program development.
• Resolves site service issues and provides expert advice to Managers regarding technical maintenance, operations or people management issues.
• Responsible for financial management of Engineering operations group.
• Works directly with operating entities to ensure that equipment maintenance, safety inspections, analyses and audits are conducted on a continuing basis as specified to enforce requirements and meet specifications.
• Oversight of outsource Facility Management model and appropriate KPIs.
• Implements and integrates equipment and systems with minimum interruption to operations.
• Participates in and may lead cross-functional project teams.
• Independently resolves a wide variety of issues of complex scope.
• Coordinates contract personnel through completion of assignments.
• Contributes to the development of new concepts, techniques, and standards.
• Ensures solutions are consistent with organizational objectives.
• Identifies, formulates, updates and monitors personnel development plans for all direct reports.
• Reviews, modifies and implements remote site’s various policies and procedures, aligning with other sites’ programs as much as possible.
• Creates and enforces new safety SOPs and policies as appropriate, to comply with manufacturing policies.
• Lead & develop site maintenance team to insure all equipment is available to meet the requirements of the business.
• Development and updating of site maintenance strategy looking at long-term issues with support, reliability, redundancy etc and the use of predicative indicators to improve equipment reliability.
• Manage service level agreements & contracts with external vendors.

Qualifications & Experience:

• Requires a degree level qualification in Science / Engineering.
• 10+ years of relevant experience and a BA or BS or related fields.
• 8+ years of relevant experience and a MA or MBA.
• Previous experience managing a cross-functional engineering team desirable.
• Working knowledge of and experience with using OEE measurement desirable.
• Previous experience in biotech or pharmaceuticals industry desirable.
• Previous experience working in highly regulated manufacturing environments desirable.
• Demonstrated ability to execute against strategic and tactical objectives provided by senior leaders both within engineering and outside of the function.
• Demonstrated ability to create an energizing team environment.
• Demonstrates ability to successfully interact with other functions on projects that involve negotiation and collaboration with cross functional peers and more senior management levels.
• Demonstrates ability to effectively manage multiple projects/priorities.
• Has proven successful experience developing and monitoring budgets and expenditures.
• Working knowledge of and experience with using OEE measurement.
• Good verbal and written communication skills and interpersonal skills are required.
• Working in a regulated environment and the requirement to follow change control procedures and qualification documentation.
• Plant maintenance experience within a regulated environment.
• Project management experience.
• Operation of a manufacturing plant maintenance and calibration system in line with GAMP & ISPE standards. Working knowledge of industry standards and guidelines such as GAMP / ISPE.
• Required to report variance or deviation from standard procedures to department management.

Summary:
Our client is a global biopharma company based in Carlow and is looking for a Process Engineer who will provide technical support for commercial manufacturing and new product introduction. The right candidate will perform product risk management and quality risk management and will Design/ Author/ Review/ Approve/ Execute process development studies in support of new product introduction and ongoing manufacturing support and qualification/validation documentation and studies in line with the standard approval process.

Responsibilities:

• Serve as technical support for commercial manufacturing and new product introduction.
• Product risk management and quality risk management.
• Management of change.
• Design/ Author/ Review/ Approve/ Execute process development studies in support of new product introduction and ongoing manufacturing support.
• Provide technical input into quality notification by authoring/reviewing/approving investigations.
• Execution of equipment/qualification validation programs; including re-qualification and re-validation.
• Design/Author/Review/Approve/Execute qualification/validation documentation and studies in line with the standard approval process.
• Perform data analysis and make informed decisions/recommendations around conclusions reached from data analysis.
• Statistical data analysis to support development and commercialisation batches.
• Support continuous improvement through Lean Six Sigma methodologies.
• Leading and active participation in projects, system failure investigations and investigation reports.
• Execution/development of change controls.
• Contribution to Kaizen events as appropriate.
• Perform root cause analysis of system failures, substandard performance, using standard tools and methods, to resolve machine and system issues e.g. FMEA, Fishbone diagrams, 5 why’s etc.
• Implement subsequent corrective action through the change management system.
• Participate and/or lead cross functional or single function teams including liaising with vendors or above site groups.
• Drive compliance of Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions, ensuring consideration of the impact on GMP and compliance and decisions made.
• Accountable for compliance via documentation completion, risk assessments, closing out corrective action, participate in audits and inspections and proactively highlighting any issues around compliance.
• Key process engineer in the commercial products engineering team to address and lead any management of changes, risks, impact assessments etc. associated with the commercial products.
• Role will report to Technical Engineering commercial support coach.

Qualifications & Experience:

• Bachelor’s Degree or higher preferred; ideally in a Science, Engineering or other Technical discipline.
• 3-5 years’ Engineering/Technical experience; ideally in manufacturing, preferably GMP Setting.
• Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices.
• Report, standards, policy writing skills required.
• Equipment and process validation.
• Sterile filling processes and equipment.
• Proficiency in Microsoft Office and job related computer applications required.
• Data analysis experience required.
• Lean Six Sigma Methodology experience desired.

Summary:
Our client a global biopharma manufacturing facility based in Dublin is seeking to recruit a contract Project Manager to lead the management and execution of projects throughout the full project life cycle from initiation to closeout. The projects will include a diverse mix of capital and expense projects on Process, Utilities and Automation/IT (AIT) systems.
Responsibilities:

• Responsible for managing a diverse portfolio of strategic projects and will have the capability to project manage multiple individual projects as the business requires.
• These will include manufacturing process projects supporting tech transfers and plant optimizations, lab equipment and capacity upgrades to support the tech transfers, and a range of projects across manufacturing and utilities.
• The successful candidate will have frequent exposure to senior management as they execute projects that shape our overall strategy and transform our site into a best-in-class Biopharmaceutical facility.
• Project execution will focus on safety, schedule, and budget adherence while complying with good engineering practices, company policies, regulations and codes.
• Accountable for meeting key project deliverables for safety, financial management, schedule management and scope management across these projects.
• Accountable for ensuring projects are compliant with good engineering practices, company policies, regulations and codes.
• Liaise with Global Engineering/Global EHS/Global Procurement to ensure all are aligned and support project deliverables.
• Accountable for strict adherence to project stage-gate principles for managing the life-cycle of projects.
• Concept and Business Case development in collaboration with project Sponsor and End user, working with the end user to understand and clarify end user requirements, develop scope, cost and budget estimates and present to governance for approval
• Leading & supporting project teams through complex and significant projects
• Financial management - develop project budgets, obtain approvals for and adhere to project scope.
• Negotiate with contractors and suppliers to keep project within budget. Make cash flow projections.
• Make effective use of SAP and budgeting tools.
• Manage project prioritization and spend to meet budgetary targets
• Project Design - Design solutions in compliance with local/corporate safety standards and legislation and in compliance with corporate engineering and regulatory standards and guidelines
• Planning and Scheduling - uses planning tools to hold a complex project on schedule and coordinate parallel activities.
• Coordinate with facilities, EHS, QA, etc. Manage external factors such as planning and inspections.
• Assure that value engineering, constructability reviews and similar processes are effectively utilized to minimize capital expenditures and maximize functional value.
• Risk Management – Identifies and categorizes project risks according to impact on scope, budget and schedule.
• Generates action plans to mitigate risks.
• Consider the potential impact construction and on time performance will have on the business should it cause an interruption and identify appropriate actions plans to mitigate risk.
• Project execution plan – Generate and deliver a detailed project execution plan concerning the execution of all aspects of the project.
• Procurement - Generate specifications for the procurement of equipment and Instrumentation, installation modification of equipment and systems, reduces equipment downtime.
• Collaborate with Procurement to ensure all procurement policies and procedures are followed.
• Innovation - seeks innovative and novel approaches for design, function and construction using operational excellence tools in improving approaches for these activities.
• Manage start-up and commissioning of all project equipment and systems as required
• Coordinate engineering support of validation activities for equipment and systems as required.
• Complete Project Close-out as per Stage Gate process.

Qualifications & Experience:

• A degree in Chemical/Mechanical/ Automation/ Process Engineering and relevant experience the pharmaceutical industry.
• Five years of project management experience across the project life-cycle within a Pharmaceutical environment.
• Demonstrable capacity to effectively manage and execute projects from initiation to completion.
• Full project lifecycle experience from end to end design through to C&Q and handover.
• Understands the project management process; programming, scope development, design development, implementation, and project closeout.
• Demonstrable experience of managing a diverse team of engineering professionals/contractors etc. to deliver projects safely, on time and within budget.
• Solid background of planning and managing engineering projects with a demonstrated record of on time performance.
• Experience managing the overall financial performance of engineering projects, including cash flow, life cycle costs, business opportunities and risks, both at a project and at a portfolio level.
• Familiar with project life-cycle stage-gate process.
• Demonstrated understanding of project management process; programming, scope development, design development, implementation, project closeout.
• Background working in multi discipline, cross functional teams.
• Experience designing complex projects within the pharmaceutical industry.
• Demonstrated experience and ability to effectively manage stakeholders.
• Excellent communication skills and the ability to influence others.
• Demonstrable experience of managing programs and/or managing a team of engineers to deliver projects.
• Experience using SAP and budgeting tools.
• Demonstrable people management skills or experience managing cross functional project teams.
• PMP ® or Chartered Engineer (CEng) status – Desirable.
• Biologic Manufacturing site experience – Desirable.

Summary:
My client is a Pharmaceutical company who is looking for a Maintenance Engineer to join their team in Cork. The successful candidate will lead equipment breakdown investigations and will work with the project teams to ensure maintenance and reliability. As a Maintenance Engineer you must be able to exercise judgement within generally well-defined procedures and practices to determine appropriate action.

Responsibilities:

• Knowledge of GMP Process.
• Ensure spare parts are linked correctly to the parent equipment.
• Ensure correct spares are in stock.
• Through data analysis and work with the craft teams identify re-occurring equipment issues and implement corrective plans.
• Introduce predictive maintenance techniques where they add value.
• Proven record of co-ordinating, leading and implementing FMECA (Failure Modes, Effects and Criticality Analysis) studies for process equipment.
• Proven track record of reviewing and simplifying PM’s through PM optimisation programme.
• Knowledge of root causes analysis techniques for equipment troubleshooting and implementation of correctives actions.
• Knowledge of process and utilities equipment.
• Participate in engineering team initiatives on an as needed basis.
• Ensure that the quality and engineering standards are adhered to.
• Ensure compliance to the Global Engineering Standards.
• Support Lab capital projects and design reviews.
• Day to day support for Lab utility and equipment related breakdowns.
• Support Lab reliability strategy.
• Assist with method statement generation and task supervisor ensuring jobs are completed in a safe manner.
• Work with Lab vendor on cost improvement initiatives and integration of Lab assets into SAP.

Qualifications & Experience:

• Minimum 3 years’ experience in Process / Project Management.
• Degree in Mechanical or Chemical Engineering.
• Chartered Engineer would be an advantage.
• Must have a thorough understanding and application of engineering principles, concepts, industry practices and standards.
• Must be able to provide solutions to moderately complex to semi-routine problems.
• Must have the ability to recognise deviations from accepted practice as required.
• Must be able to apply knowledge of current Good Manufacturing Practices (cGMPs).

• To compile and own the Calibration Standard Operating Procedure.
• To proactively schedule and coordinate all calibrations on site
• To manage the financial budget for the department
• Continually monitor effectiveness of the calibration system
• To ensure all staff in the calibration department are adequately trained and supervised.
• Be aware of the required technical standards regarding the calibration.
• To proactively schedule and execute all calibrations on site, including oversight of calibration vendors.
• To represent the calibration department within value streams (e.g. pulse walks & gallery walks)
• To ensure you are continually upskilling on key calibration procedures and equipment (e.g. CMMQ, hand-held gauges, measurement instrumentation for new projects)
• Supervise and train junior staff on base business calibration techniques.
• Be flexible with the day-to-day schedule to accommodate urgent calibration requests.
• Continually monitor effectiveness of the calibration system and maintain positive Calibration Department metrics.
• To proactively schedule and coordinate all calibrations on site.
• To oversee all vendors brought on site for calibration purposes.
• To manage the shipping & receipting of gauges to external vendors for calibration
• Be aware of the required technical standards regarding the calibration.
• Be aware of the “State of the Art” equipment used in the manufacture and inspection of J&J products.
• Engage with Value Streams, NPI, and Project teams as necessary on calibration related requirements.

• Actively promote a safety culture.
• All employees are responsible for minimizing both the Environmental and Health & Safety effects of the work that they perform
• Manage contractors / vendors working on site to ensure full compliance with site safety requirements.

• Identify opportunities to reduce excess equipment within calibration system
• Identify methodology where calibration frequency can be reduced, i.e. extend periods between calibrations
• Manages to Calibration budget monthly and reports to management
• Provide Calibration input into the value stream mapping process which is used to develop the business plan for the value stream.

• Support day to day operations through attendance at pulse walks and the timely closure of actions across the calibration team.
• Provide support to the wider business team in Root Cause Analysis of calibration and quality issues as they arise through tools such as A3 and Six Sigma.

• Ensure timely closure of quality actions such as Training, Audit Actions, NR’s, CAPA’s across the team.
• To represent the calibration department in quality and compliance audits
• Works to ensure all calibrations are completed on time

• Work with Manager/Team Leader to develop and implement strategic Calibration Goals & Objectives.
• Identifies scope for improvement and a willingness to get involved in related projects

• Ability to manage multiple assignments or projects with sound analytical, trouble-shooting, and problem-solving skills.
• Flexible work ethic.
• Strong influencing skills.
• Excellent communication and presentation skills.
• Has the drive, energy and enthusiasm for delivering to commitments.
• Excellent planning & organisation skills with an attention for detail.
• Extent of confidentiality - discretion is essential in view of contact with outside parties, product development strategies, regulatory and sales information.

• Engineering background preferably in the Mechanical Engineering area either at Certificate (L6) or higher
• Understanding of requirements for calibrating to National / International standards
• Computer Literacy – Word, Excel, Access, etc.
• Good experience as a Calibration Technician/Engineer in an Engineering / Medical Devices company

• Experience in regulated industry, FDA, ISO, etc.
• Good team player/flexible
• Attention to detail
• Logical & Analytical Approach
• Good Planning & Organising Skills
• Understanding of requirements for calibrating to National / International standards
  

• Reporting to the Automation & IT Project Manager, specifically responsible for Implementation of Continuous Manufacturing Automation Systems as part of a larger project.
  
• This candidate will be required to work closely with the Automation & IT teams responsible for the full Automation and IT scope and with vendors / partners with responsibility for delivery of systems.
  

• As the senior Automation Engineer, you will Manage Automation vendors and provide clear direction for the Automation team.
  

• Requirements Specifications
  
• Requirements Traceability Matrix
  
• Functional Specification
  
• Design Specification
  
• Code Review
  
• Test specification/test script
  
• Etc.
  

• Develop an understanding of the complete operation of the CM and follow development of coding efforts from concept to FAT
  
• Ensure delivery of code is robust, stable and delivers a system which runs compliantly and efficiently in conformance with company standards for infrastructure, DI and throughput needs of business (OEE > predefined metric)
  
• Work closely with vendors of Automation equipment to ensure deliverables meet project requirements, including the interfacing of new Automation equipment with existing site systems, incl. MES and PI Historian.
  
• Work closely with the QA-IT and CSV functions and ensure their requirements are met in all deliverables.
  
• Participate in Hardware and Software FATs and SATs to ensure requirements and standards are met.
  
• Develop project schedules and document trackers to manage and control project deliverables.
  
• Lead Automation meetings and support, relevant program meetings.
  
• Liaise with stakeholders on the overall project to ensure clear communication between all parties.
  
• Ensure Automation compliance with Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions.
  

Requirements

• Fluent in English, written and verbal.
  
• Minimum of 6 years’ experience in a similar role in the Pharmaceutical industry.
  
• Strong experience in the following systems: Siemens S7 PLC, WinCC SCADA and HMIs
  
• Experience in one or all of the following systems would be advantageous: Other PLC, SCADA and HMIs, Siemens Desigo, OSISoft PI, RT Reports, PasX MES.
  
• The successful candidate may sometimes be required to attend meetings at other MSD sites, attend FAT testing at vendor premises and attend meetings at vendor premises as required.
  
• Excellent computer skills, proficient in the use of the following Microsoft tools: Excel, SharePoint, Word and PowerPoint.
  
• Strong interpersonal and communication skills (verbal and written).
  
• Relevant Computer Science or Engineering degree or equivalent
  
• Previous experience of Continuous Manufacturing is desired.
  
• Previous experience of Oral Solid Dose manufacturing will be advantageous. • Previous experience of high containment manufacturing will be advantageous.
  

PACIV, a global leader in industrial automation solutions with offices in Puerto Rico, United States and Ireland, and servicing the Life Sciences, F&B and Utilities industries, is looking for a Process Analytical Technologist (PAT) Engineer for its client in the Munster area..

Role Description

• The  PAT & Labs engineer will be responsible for delivery of Process Analytical Technologies and Lab equipment scope on one or more projects in the portfolio of capital projects managed by  our customers Global Engineering Solutions  team.
• This candidate will be required to work closely with the  Automation/IT  teams responsible for the full Automation and IT scope and with vendors / partners with responsibility for delivery of systems.

Responsibilities

• Partner with local project teams to deliver Automation and IT aspects of Process Analytical Technologies and Laboratory systems for capital projects.
• Develop and/or review System Development Life Cycle (SDLC) deliverables, compliant with  standards.
• The expectation is that this role will grow to be the PAT SME for  project teams. Successful candidate should Coach, mentor and provide technical training to colleagues.
• Understand and educate local project teams on automation standards as they relate to technology selection, system configuration, SDLC, validation, hardware, software environments and business processes.
• Work closely with the QA-IT function to ensure compliance with Client  Quality standards.
• Provide input to the development of project schedules and document trackers.
• Participate in, and support, relevant project meetings.
• Engage with stakeholders at all levels of projects.
• Ensure that SDLC is appropriately applied

Skills and Qualifications

• BS in Engineering, Computer Science, or other technical degree.
• Specific experience in the design, implementation and qualification of Process Analytical technologies is a requirement – SIPAT is preferable, Multivariate analysis, NIR and other technologies.
• Familiarity with real time release using PAT technologies would be advantageous.
• Experience with Process Automation systems and/or Laboratory systems in a Life sciences environment is desirable.
• 3 or more years of experience in project automation/IT support in a Life Sciences environment with direct technical and SDLC experience.
• Excellent facilitation, problem solving, and decision-making skills.
• Demonstrated ability to analyse and define business problems, develop business cases, and identify appropriate process and technological solutions is essential.

• Proven facilitation, meeting/workshop management, project management and change management skills are essential.

• Excellent written and oral communication skills, as well as strong presentation skills.
• Experience with Laboratory systems such as LIMS, Empower and Nugenesis

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 Job Responsibilities

• Working with process and project engineering to plan and deliver automation projects.
• Responsible for Automation Engineering design and Automation.
• Lead and Participate in cross functional teams to troubleshoot and resolved technical issues.
• Ensure relevant Automation systems documentation is prepared and updated in LINE with all Quality and regulatory guideline and promotes full compliance to all GMP, environmental and safety requirements. 
• Plan and deliver automation projects.
• Required to comply with Company Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good Manufacturing Practices (cGMP) in the performance of day to day activities. 
• Providing coaching and support to the Operations team to build their knowledge of Automation systems. 

Job Requirements

• 3+ years Pharma Experience.
• PLC & SCADA programming.
• Wonderware, Siemens, Wonder knowledge an advantage.
• Excellent written and verbal communication skills.
• A self-starter with an ability to work on own initiative.

For a confidential discussion on this or any other current job opportunity please contact Meggan on 021 235 9144 / mtully@sigmar.ie

Following your application for this specific role, Sigmar may contact you regarding other positions that we feel you may be suitable for. If you do not wish to be contacted about other opportunities please let us know. For further information please refer to the Privacy Statement on our website.

Following your application for this specific role, Sigmar may contact you regarding other positions that we feel you may be suitable for. If you do not wish to be contacted about other opportunities please let us know. For further information please refer to the Privacy Statement on our website.

Following your application for this specific role, Sigmar may contact you regarding other positions that we feel you may be suitable for. If you do not wish to be contacted about other opportunities please let us know. For further information please refer to the Privacy Statement on our website.