• You will be an active member of the shift team to resolve EHS, Quality and Operational issues within the shift
• Manage a comprehensive Preventive and Corrective Maintenance programme in assembly and corrective maintenance in all other operational areas of the site and ensure that documents are audit ready to meet compliance and regulatory requirements
• Working with the Process Engineers, identify areas of problems/opportunities in existing equipment and detail possible improvements following up with production, tool room and outside resources as appropriate.
• Manage small improvement projects as required
• Participate in Continuous Improvement initiatives as appropriate - Kaizen, Lean, LDMS, Blitzes.
• May be required to act as a back up user to the site computerized calibration tracking system.
• Work with direct reports to carry out risk assessments, behavioural based audits, close out near miss action items on a regular basis.
• Work with immediate manager to review machine spares and ensure that necessary spares and stock levels are set up in stores
• Identify the development and training needs of direct reports and coordinate with immediate manager to prepare a comprehensive plan
• Any other reasonable duties which may be required by management from time to time

• You will be Degree qualified (ideally Electrical, Mechanical or Production Engineering)
• You will have 3-5 years' experience in a similar role with direct people management experience.
• You will be able to work and communicate in a cross functional environment and will be familiar working in a regulated, high volume and very automated environment
• You will have knowledge of PLCs, Vision Systems, High Speed Assembly and Packaging operation would be preferred.

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.

·        Serve as technical engineering representative for internal technical group discussions and represent technical Operations at global technical forums.

·        Participate and/or lead cross functional or single function teams including liaising with vendors or above site groups.

·        Drive compliance of site 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.

·        Work collaboratively to drive a safe and compliant culture on site.

·        May be required to perform other duties as assigned.

Skills

·        Excellent communication, presentation and interpersonal skills, to interface effectively with all levels of colleagues and with external customers in a team orientated manner

·        Understand the specific responsibilities of all site departments as they relate to other departments

·        Bachelor’s Degree or higher preferred; ideally in a Science, Engineering or other Technical discipline

·        Would typically have prior related work experience; ideally in manufacturing, preferably GMP Setting

To apply contact Martin Lynch on 087-344 3581.

Email CVs to

Responsibilities

·        Manage multiple projects from scope development, design, build/install and qualify through to handover to operations for key Engineering projects on site.

·        Use scientific, product and process understanding as a basis for developing risk-based approaches to investigations and troubleshooting that will feed into future projects

·        Develop project scope, cost and delivery time schedule for projects, working and collaborating closely with NPI leads to ensure integration into ongoing Validations and/or Technical transfers

·        Collaborate closely with cross functional teams to establish scope in improvement projects on site as we ramp up to a fully commercial site

·        Be accountable for equipment design and qualification; assisting in C&Q execution planning; system boundary definition, system level and component criticality impact assessments, use of quality risk management, User Requirement Specs. And requirements traceability matrices, Document Mgt. Systems, FAT/SAT and C&Q protocol development, project implementation

·        Drive and support continuous improvement by active participation in projects, system failure investigations and investigation reports, execution/development of change control, and contribution to Kaizen events as appropriate.

·        Act as a liaison with both global engineering services and facilities as well as specialist vendors to deliver projects on time and in full as required by the business

·        Comply 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, 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

·        Work collaboratively to drive a safe and compliant culture on site.

·        Collaborate with multiple partners (e.g. Company network groups, third parties, vendors, quality, donor sites, Supply chain, IPT).

·        Presentations and reporting out on progress of projects to stakeholder as required.

·        Managing vendors for work on site ensuring compliance with safety and permitting requirements for all on site activities.

Skills

·        In depth knowledge and experience of Sterile filling processes and equipment especially aseptic processing

·        Experience of executing and/or managing through equipment and process design and validation in a sterile environment

·        Excellent report, standards, policy writing skills required

·        Automation and MES knowledge

·        Proficiency in Microsoft Office and job-related computer applications required

·        Lean Six Sigma Methodology experience desired

·        Experience in audit preparation and execution desired

·        Having a strong safety ethos

·        Have proven record of process improvement implementation

·        Have a proven record of project management of change in a commercial site

To apply contact Martin Lynch on 087-344 3581.

Email CVs to

An expansion of the site, an exciting opportunity has come to join the Commercialisation team to transition from a project phase to a fully operational facility delivering life-saving products to patients.

Responsibilities

·        Oversee equipment C&Q within the assigned area with a view to ensuring right first-time C&Q and Validation effort.

·        Act as validation SME on the equipment within the area assigned.  As such you will be leveraging testing from Commissioning and Qualification.

·        Providing technical and validation oversight to process, design and project delivery teams and coaching to associate staff within the assigned suite.

·        Implementing the requirements as outlined in the site / project Validation Master Plan.

·        Engage in the early stages of the project, giving input into design by working with equipment vendors and global engineering teams, attending FAT and design reviews to represent client validation interests.

·        Coordination of engineering sub-teams in the assigned suite during execution of Cycle Development & Validation activities.

·        Authoring and reviewing standard operating procedures and technical reports including PQ protocols.

·        Technical review and approval of Commissioning protocols, Qualification protocols and Validation protocols executed by vendors, cross functional groups and/ or validation counterparts.

·        Supporting regulatory submissions as required.

·        Owning Change Management process for Equipment introduction within the assigned suite for qualification / validation up to PQ stage.

·        Lead and support various organizational initiatives as needed (examples include EHS, workload forecasting, work standardization, etc).

·        Represent the site in internal collaborations through Manufacturing Division Validation Communities of Practice to include sharing of best practices in validation and investigation activities.

·        Keep up to date with scientific and technical developments, best practices and attend seminars as required.

·        Maintain continuous focus on quality and safety compliance and unflinching focus on the customer.

·        Execution in line with the site Continued Process Validation (CPV) program and supporting cross-site CPV as needed.

Education & Experience

·        5 years directly related experience in academia, pharmaceutical or biotechnology industry – along with a working knowledge of current regulatory requirements and current Good Manufacturing Practices.

·        Minimum 3 years process equipment C&Q/ Validation experience on Large Scale Projects

·        SME on Equipment Validation on any of; CIP & Parts Washer / SIP / Autoclaves / DHT & Electron Beam sterilisation / Vaporised Hydrogen Peroxide Sterilising Isolators / Clean Utilities Transfer Panels & Formulation Vessels

·        Working knowledge of ASTM E2500 / Eudralex / FDA / ISPE guidelines

·        Experience with liaising with other departments – engineering, technical, operations and QA

·        Experience with sterile processing and sterilisation technologies

·        Experience with cleaning and process validation, technology transfer, regulatory filing, and commercial drug product manufacturing of biologics is a plus.

·        Prior experience in drug product processing equipment, PQ, Process Performance Qualification and Validation, site readiness, batch record reviews, authoring documents subject to regulatory inspection.

·        SIP and CIP subject matter extensive experience

·        Autoclave Qualification and Sterilisation Loads Cycle Development experience

·        Use of temperature mapping equipment such as Lives/ Kaye etc. and trending, analysing and interpreting complex data

·        Warehouse and CTU qualification

·        Visual Inspection technologies for Vial & Syringe

·        Vial & Syringe processing technologies; drug product filling, glass handling, tray handling, stoppering, capping and CCI.

·        New facility brown/ green field facility experience

·        Small equipment qualification and validation; FITs, Scales, Tube Sealers/ Welders, Headspace analysers, Flowmeters, Mobile Vessels & Single Use Technologies.

·        Project Management experience / training in use of Project Management tools.

To apply contact Martin Lynch on 087-344 3581.

Email CVs to

The CSV engineer will be responsible for the development of key AIT quality documents, such as Quality Assurance (QAPs) and test plans, and for ensuing adherence to the QAPs. This candidate will be required to work closely with the site AIT teams responsible for the full Automation and IT scope and with vendors / partners with responsibility for delivery of systems.

Responsibilities

·        Develop and maintain Qualification Plans and Test Plans, aligned with the overall project C&Q plan and with the leveraging strategy.

·        Develop templates for all SDLC deliverables, compliant with site standards, to ensure consistent implementation of the validation strategy, including but not limited to:

o   Requirements Specification

o   Requirements Traceability Matrix

o   Functional Specification

o   Design Specification

o   Code Review

o   Test specification/test script

·        Work closely with the QAIT function and ensure their requirements are met in all deliverables.

·        Align with the site HPV program: leverage existing documents & expertise where feasible

·        Approver of all AIT SDLC deliverables, ensuring compliance with standards

·        Provide FAT oversight and perform leveraging assessments,

·        Provide guidance and support to AIT team members tasked with delivery of SDLC documents

·        Provide input to the development of realistic project schedules and document trackers

·        Work closely with suppliers / integrators to ensure compliance with site standards

·        Participate in, and support, relevant project meetings

·        Liaise with the various stakeholders on the overall project to ensure clear communication between all parties in relation to AIT validation requirements.

·        Support the Automation team with field instrument configuration, connectivity to their associated control system and loop testing.

Education & Skills

·        Fluent in English, written and verbal.

·        Minimum of 3 years’ experience in a similar role, ideally in the Pharmaceutical industry.

·        Expert knowledge of GAMP5.

·        Strong experience in one or all of the following systems: DeltaV, PCS7 (or other PLC/SCADA), OSI PI.

·        The successful candidate may sometimes be required to attend meetings at other sites, off-site or at the PM office in Cork.

·        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

To apply contact Martin Lynch on 087-344 3581.

Email CVs to

An exciting opportunity has come to join the Commercialisation team to support the transition from a project phase to a fully operational facility delivering life-saving products to patients.

Responsibilities

·        Engage in the early stages of the project, giving input into design by working with equipment vendors and global engineering teams to represent client Validation interests. Oversee equipment C&Q within the assigned area with a view to ensuring right first-time C&Q and Validation effort.

·        Act as validation SME on the equipment within the area assigned.  As such you will aim to leveraging testing from Commissioning and Qualification where possible.

·        Providing technical and validation oversight to process, design and project delivery teams and coaching to associate staff within the assigned suite.

·        Implementing the requirements as outlined in the site / project Validation Master Plan.

·        Coordination of and participation in engineering sub-teams in the assigned suite during execution of Cycle Development & Validation activities.

·        Authoring and reviewing standard operating procedures and technical reports including PQ protocols.

·        Willingness and ability to support morning / evening shift work during critical periods within the project lifecycle (Cycle Development and PQ).

·        Technical review and approval of Commissioning protocols, Qualification protocols and Validation protocols executed by vendors, cross functional groups and/ or validation counterparts.

·        Supporting regulatory submissions as required.

·        Owning Change Management tasks for Equipment introduction within the assigned suite for qualification / validation up to PQ stage.

·        Effective application of LeanSixSigma and Change Management tools

·        Lead and support various organizational initiatives as needed (examples include EHS, workload forecasting, work standardization, etc).

·        Represent the site in internal collaborations through Manufacturing Division Validation Communities of Practice to include sharing of best practices in validation and investigation activities.

·        Keep up to date with scientific and technical developments, best practices and attend seminars as required.

·        Maintain continuous focus on quality and safety compliance and unflinching focus on the customer.

·        Execution in line with the site Continued Process Validation (CPV) program and supporting cross-site CPV as needed.

Education & Experience

·        Minimum 3 years process equipment C&Q/ Validation experience

·        SME on Equipment Validation on any of; SIP / Autoclaves

·        Working knowledge of ASTM E2500 / Eudralex / FDA / ISPE guidelines

·        Experience with liaising with other departments – engineering, technical, operations and QA

·        Experience with sterile processing and sterilisation technologies

·        Experience with validation, technology transfer, regulatory filing, and commercial drug product manufacturing of biologics is a plus.

·        Prior experience in drug product processing equipment, PQ, Process Performance Qualification and Validation, site readiness, batch record reviews, authoring documents subject to regulatory inspection.

·        SIP and subject matter extensive experience

·        Autoclave Qualification and Sterilisation Loads Cycle Development experience

·        Use of temperature mapping equipment such as Lives/ Kaye etc. and trending, analysing and interpreting complex data

·        Experience with process validation, technology transfer, regulatory filing, and commercial drug product manufacturing of biologics is a plus.

·        Warehouse and CTU qualification

·        Visual Inspection technologies for Vial & Syringe

·        Vial & Syringe processing technologies; drug product filling, glass handling, tray handling, stoppering, capping and CCI.

·        New facility brown/ green field facility experience

·        Small equipment qualification and validation; FITs, Scales, Tube Sealers/ Welders, Headspace analysers, Flowmeters, Mobile Vessels & Single Use Technologies.

·        Project Management experience / training in use of Project Management tools.

·        Experience of DHT & Electron Beam, VHP Isolators also beneficial.

·        Prior experience in drug product processing equipment, PQ, Process Performance Qualification and Validation, site readiness, batch record reviews, authoring documents subject to regulatory inspection

To apply contact Martin Lynch on 087-344 3581.

Email CVs to

Role Purpose:

Reporting to the Human Resources Manager, the Training and Development Specialist will coordinate primarily with the quality and operations department to provide a high-quality training service that promotes and supports excellence in operations in a high-volume manufacturing environment. The Training and Development Specialist will facilitate effective learning interventions related to product, process, quality, health and safety, etc.

Key Requirements:

• Design and deliver training processes relating to product, process, quality, health and safety, using methods such as TNA and/or gap analysis to identify training needs
• Keep updated in relation to operational and/or quality-related changes within MGS Mfg. Group Ltd (Ireland) and take action accordingly to provide any necessary support that may be required from a training perspective
• Alongside the Quality System Engineer, support the review and re-design of documentation (e.g. SOPs, WIs, etc.) for training and other cGMP systems to enable improvements.
• Support internal and external quality and operational audits of the training function
• Maintain comprehensive, accurate and up-to-date training records and systems in compliance with all internal and external requirements/standards, to include measuring and recording key training metrics, complying with GDPR regulations and practising relevant retention period timelines
• Proactively foster health and safety awareness and continuous improvement within the MGS Mfg. Group Ltd (Ireland)
• Coordinate re/training of existing colleagues in partnership with internal stakeholders to meet specific training needs.
• Have the ability to analyse the current training process, identify gaps and roll out improvements
• Support the wider team in identifying external training platforms and/or programs to address specific training needs and making recommendations about appropriate training solutions where necessary
• Coordinate logistics in relation to both internal and external training activities to ensure all training facilities are conducive to creating a positive learning environment.
• Facilitate learning through a variety of delivery methods including classroom instruction, on-the-job coaching, etc.
• Follow-up on training and performance initiatives with colleagues to ensure the effectiveness of learning interventions.

Other Responsibilities:

• Support the HR department as required in the recruitment and onboarding process for new colleagues.
• Help coordinate and carry out the induction and training of new colleagues.
• Actively contribute to cross departmental projects and initiatives in relation to training.
• Engage in continuous professional development.
• Other duties and responsibilities that may be reasonably assigned by management.

The ideal candidate:

The Training and Development Specialist will be a self-starter, possessing excellent interpersonal, teamwork, IT and communication skills. Previous training experience is essential, ideally within a manufacturing environment. An understanding or experience with GMP, GDP and/or ISO standards is preferred. He/She will also be able to work with a high degree of discretion and confidentiality. The Training and Development Specialist will have a demonstrated track record in the delivery of goals and improvements and experience of working under pressure to tight deadlines. It is also highly desirable that the Training and Development Specialist holds a Training and Development qualification or equivalent, and experience in lean techniques and projects.

MGS is an equal opportunities employer

ROLE PURPOSE:

To assist the Engineering and Production teams to continuously improve the manufacture of product by designing, operating and implementing optimal moulding, tooling and automation processes that maintain efficiency, reduce cost, improve sustainability and maximise profitability. The Process Engineer provides technical expertise to ensure that current and future projects run in accordance with company and customer standards and specifications

ROLE RESPONSIBILITIES:

• Responsible for the successful execution of Process Engineering projects designed to deliver robust and optimized manufacturing processes, as well as the provision of day-to-day technical support and expertise to the Production teams.

• Conduct product investigations; equipment and process related troubleshooting, and root cause analysis, implementing appropriate corrective and preventative actions where necessary.

• Assist the timely introduction of new products and/or processing technologies from development stage through to routine full-scale manufacture, ensuring a cost effective, compliant and robust process is achieved.

• Assist the introduction and validation of new tooling & equipment to include the completion of validations and documentation where required.

• Support the introduction and transfer of new moulds into production.

• Liaise with external toolmakers and equipment suppliers in relation to critical technical specifications.

• Support all departments, particularly Quality and Tooling, in relation to Engineering changes.

• Provide technical support and expertise as required to achieve process optimisation and/or new product introduction.

• Make process decisions based on risk and the interpretation of data sets ensuring consultation and communication with stakeholders.

• Apply a project management approach to successfully deliver projects and process improvements on time and in budget, while appropriately managing risk.

• Demonstrate a high level of accountability and ownership for both personal and team performance.

• Train, coach and mentor colleagues (e.g. Technicians, Supervisors, etc.) on new technologies and/or manufacturing processes.

• Ensure highest Quality & Compliance standards, participating and complying with the Quality Management System.

• Identify and generate opportunities for improvement and actively participate in the implementation of corrective action plans and continuous improvement initiatives.

• Comply with all company policies and procedures, including quality requirements, financial controls, health and safety regulations, etc.

The above list of duties and responsibilities is not exhaustive, and the role holder may be required to carry out other duties which may reasonably be assigned by management

THE IDEAL CANDIDATE WILL:

• Have a minimum of a third level qualification in a relevant field (e.g., Engineering, Manufacturing Systems, Polymer Processing, or similar). 

• Have extensive and directly relevant experience as a seasoned Process Engineer in high-volume injection moulding manufacturing, including demonstrable process validation and project management experience.

• Have experience in validation activities from design & FAT right through to PQ.

• Be proficient in the use of Lean Manufacturing principles (SMED, Six Sigma, etc.).

• Possess excellent interpersonal skills and the ability to successfully manage stakeholder relationships.

• Possess excellent verbal and written communication skills.

• Have comprehensive knowledge of QMS principles (preferably ISO 13485)

• Have strong information management, analytical and numerical skills with a high level of attention to detail.

• Be a team player and capable of working independently and on own initiative.

• Be well-organised, highly self-motivated and capable of multi-tasking in a fast-paced, pressurised environment.

• Experience using MS Project to track & deliver moulding/tooling/automation projects would be a distinct advantage.

• Be flexible to travel on company business.

MGS is an equal opportunities employer