Summary:
A global bio pharmaceutical company based in Carlow is looking for a Technical Transfer Specialist to join it’s growing team. The successful candidate will be responsible for the transfer of a syringe and/or vial commercial product from the existing lines to the newly expanded facility, as well as the transfer of a formulation process from a US site. As part of your role you will be working with a cross functional team to ensure that all aspects of the technical transfer process will be adhered to and you will be expected to collaborate with multiple internal and external departments. The role will include early engagement with the construction team to ensure that process requirements are embedded into equipment and facility design and construction while helping to build and execute the technical transfer plan for the product. Process development studies and engineering batches will lead up to the goal of completing the Product and Process Qualification batches in 2022.

Responsibilities:

• Within this role you will be working within the technical transfer team, reporting to the Technical Transfer Lead.
• Execute process engineering activities to support the technical transfer of products to site.
• This includes but is not limited to: engineering studies, equipment tuning, development batches, single use component fit checks, process simulations, PPQ’s, etc.
• Engage in the early stages of the project, giving input into design by working with equipment vendors and global engineering teams to ensure that the process and product requirements are met.
• Provide technical and product guidance to the process, design and project delivery teams.
• Author and review procedures and technical reports as required as part of the technical transfer.
• Review and approve Validation protocols executed by vendors, cross functional groups and/ or validation counterparts.
• Lead and support component criticality assessments for the process and create control strategies.
• Execute activities as part of the Change Management process for the product introduction.
• Apply Lean Six Sigma and Change Management tools to identify process improvements.
• Represent the site in internal collaborations with Technical Transfer and Commercialization teams to include sharing of best practices.
• 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.

Qualifications & Experience:

• This role requires an experienced individual with a minimum of 2 years directly related experience in academia, pharmaceutical or biotechnology industry – along with a working knowledge of current regulatory requirements and current Good Manufacturing Practices.

• Process or technical transfer experience.

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

• Experience with sterile processing and sterilisation technologies

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

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

• Familiarity with equipment within a sterile fill finish environment; e.g. CIP & Parts Washer / SIP / Autoclaves / DHT & Electron Beam sterilisation / Vaporised Hydrogen Peroxide Sterilising Isolators / Clean Utilities Transfer Panels & Formulation Vessels.

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

• New facility brown/ green field facility experience.

• Process development and experiment design experience.

   

Summary:
My client is a Biopharmaceutical company who is looking for a Support Utilities Engineer to join their team in Carlow. The successful candidate will provide technical expertise within engineering group to deliver the maintenance program for side wide utilities systems and its associated infrastructure.
Responsibilities:

• Participate in equipment walkdowns for new projects to ensure compliance with standards.
• Review maintenance and project technical information including “Turn Over Documentation”, correctives, work orders and safety assessments to ensure documentation is accurate.
• Drive the on boarding on new equipment and ensure maintenance plans are updated as per manufactures recommendations.
• Updating of system descriptions and work routine as required for new project equipment /systems.
• Delivery of in-house utilities improvement projects with maintenance contractor and system vendors.
• Attend both project and maintenance meetings as required.
• Resolve issues and escalate risks in a timely fashion to the relevant on-site stakeholders.
• Comply with the current Manufacturing Division, Quality and EHS Management System requirements, as relevant to the project and commercial operations.

Qualifications & Experience:

• Diploma or Degree qualification or equivalent.
• A minimum of 2 years’ experience in utilities systems and equipment integration.
• A minimum of 2 years technical experience delivering utilities maintenance and projects.
• Experience in Pharma/ Medical devices/ Food industry (ideally working with support utilities) and familiarity with a highly regulated environment.
• Demonstrated site operations project experience, from capital project to continuous support to manufacturing operations.
• Proficiency in Microsoft Office and job-related computer applications.
• Evidence of continuous professional development is desirable.
• Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices.

Summary:
My client is a Biopharmaceutical company who is looking for an Electrical Engineer to join their team in Carlow. The successful candidate will provide technical expertise within engineering group to deliver the maintenance program for side wide electrical and life safety systems and its associated infrastructure.
Responsibilities:

• Participate in electrical walkdowns for new projects to ensure compliance with standards.
• Review maintenance and project technical information including “Turn Over Documentation”, correctives, work orders and safety assessments to ensure documentation is accurate.
• Drive the on boarding on new equipment and ensure maintenance plans are updated as per manufactures recommendations.
• Updating of system descriptions and work routine as required for new project equipment /systems.
• Delivery of in-house electrical improvement projects with maintenance contractor and system vendors.
• Attend both project and maintenance meetings as required.
• Resolve issues and escalate risks in a timely fashion to the relevant on-site stakeholders.
• Comply with the current Manufacturing Division, Quality and EHS Management System requirements, as relevant to the project and commercial operations.

Qualifications & Experience:

• Diploma or Degree qualification or equivalent.
• 2 years’ experience in electrical systems such as Main LV distribution, life safety systems, security systems and equipment integration.
• 2 years’ technical experience delivering electrical maintenance and projects.
• Experience in pharmaceutical/medical devices/food industry and familiarity with a highly regulated environment.
• Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices.
• Proficiency in Microsoft Office and job-related computer applications.
• Delivery of safety, performance and quality goals.
• Demonstrated site operations project experience, from capital project to continuous support to manufacturing operations.
• Proven track-record in delivering results in a world-class supply organisation.
• Evidence of continuous professional development is desirable.

Senior DeltaV Engineer- Project Automation

Carlow

Exciting opportunity to join a leading pharmaceutical in Carlow as Senior DeltaV Engineer- Project Automation

The ideal candidate will be responsible for the development of key documentation, test protocols, and for ensuing adherence GAMP practices Systems & full Automation and IT scope and with vendors / partners.

Job Responsibilities

• The Senior DeltaV engineer will be responsibility to the delivery, and qualification of DeltaV Process Areas
• Be part of the DeltaV team contributing to the completion of a large-scale project
• Support the project on a day to day basis for the DeltaV System including: Design and test documentation generation, reviewing and approving
• Supporting of PLC system interfacing with the DCS system
• Design, Review, Approve SDLC deliverables, compliant with the company standards, to ensure consistent implementation of the validation strategy, including but not limited to:
  • Requirements Specification
  • Requirements Traceability Matrix
  • Functional Specification
  • Design Specification
  • Code Review
  • Test specification/test script
• Work closely with QAIT and ensure their requirements are met in all deliverables
• Participate in Hardware and Software FATs
• Provide input to the development of realistic project schedules and document trackers
• Work closely with suppliers / integrators to ensure compliance with the company 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.
• Required to 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.

Job Requirements

• Fluent in English, written and verbal.
• Minimum of 5 years’ experience in a similar role, ideally in the Pharmaceutical industry.
• Working knowledge of GAMP5
• Excellent knowledge of DeltaV
• Relevant Computer Science or Engineering degree or equivalent
• Excellent computer skills, proficient in the use of the following Microsoft tools: Excel, SharePoint, Word and PowerPoint

For a confidential discussion on this or any other current job opportunity please contact MarcelSkolimowski on 021 4847 138 / 

marcel@sigmar.ie

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Job Description

• Safe and efficient operation of site life systems, such as Fire Alarm, Gas Detection and Access Control.
• Effective contractor management.
• Continuous improvement initiatives to enhance the operations in Facility areas.

• Responsibility for the operation and maintenance of all site Facility systems on site, including but not limited to; Access Control, Fire Alarm System, Pest Control, Security, Site Communications, Sprinklers, Grounds & Building Fabric Maintenance, Plant Uniforms & General soft services.
• Ensure all regulatory compliance requirements are fulfilled.               
• Ensure correct spares are specified and maintained at adequate levels to maintain operations.
• Operate planned and unplanned maintenance systems as defined in Engineering Department procedures.  Implement procedures for new equipment as required.  
• Develop and implement maintenance strategies and plans for all equipment in Facilities.
• Manage Department performance against defined KPIs.
• Control and monitor safe working practices of team members and contractors while on site.
• Support the Technology Transfer initiatives for incoming new products. This requires good communication and close cooperation with key Technology Transfer personnel from other departments.
• Implement training programs and maintain up to date training records for key contractors such as Security personnel.       
• Instigate maintenance improvement projects to improve availability and efficiency.
• Lead quality investigations relating to Facility systems.
• Ensure compliance with the Quality Department Document Management System.
• Participate in the control of Safety and Environmental programmes.  Adhere to safe working practices as set out in the Safety Statement and other company safety rules.
• Participate fully in cross-functional training initiatives.
• Provide regular reports on the activities of the Facility & Utility group
• Assist with the formation and control of operational budgets.

• Leadership of site programmes to manage certain High Risk activities.
• Participate in site EHS activities and ensure that the Facility personnel comply with legislation and best practice.
• Actively foster an ethos and culture of safety awareness, where safety is accepted as an integral part of the overall business.
• Work with all GC personnel, contractors and visitors to ensure that all safety policies, procedures and regulations are fully adhered to across the site on an ongoing basis.
• Ensure compliance with legislative requirements as applicable to engineering/ maintenance systems.

• Ensure that team are well trained to safely and effectively carry out their roles. Develop training for relevant personnel with a particular focus on direct operational and technical support personnel.
• Preparation and delivery of training material as required.
• Ensure timely completion of all SOP training and assessment tasks.
• Ensure that all training and assessment is accurately and promptly recorded for themselves and other relevant personnel in accordance with TILGC procedures.
• Maintain and improve their professional knowledge base. Keep up to date with all current trends and relevant legislation.

• Participate fully in any cross functional training initiatives.
• Drive and promote the corporate values of Takeda-ism within the workplace.
• Actively foster, in cooperation with other TIL staff, an ethos and culture of safety awareness where safety is accepted as an integral part of the overall business. Ensure that Accident Reports / Beacon Events are completed in a timely manner after an event.

• Ensure timely completion of all SOP, reading, training and assessment.

• Other duties as required and directed by the relevant Manager or other Officer appointed by the Board of Directors.

• 3rd level Engineering, or equivalent, required.

Locations

Grange Castle, Ireland

Worker Type

Employee

Worker Sub-Type

Regular

Time Type