Senior Equipment Engineer

Life Science Recruitment; Dublin; On-site; EUR 70,000 - 90,000; Full time

Job summary

Life Science Recruitment seeks a Senior Equipment Engineer for an onsite 12-month contract in Dublin. You will drive expert validation support across the full lifecycle, coordinating qualification activities for Vial and Syringe filling, formulation, inspection and clean utility areas in line with GMPs.

The role requires 6+ years in validation/commissioning management, a relevant engineering or science degree, and experience with sterile/biotech equipment in pharma.

Qualifications

• 6+ years experience in science, engineering or validation, commissioning and qualification management.
• Technical qualification at third level or equivalent in Engineering or science.
• Extensive experience managing commissioning and qualification for Pharmaceutical/Biotech projects.
• Experience with sterile/biotech equipment within pharmaceutical industry is preferred.

Responsibilities

• Provide expert technical validation support across the full lifecycle from design to validation maintenance (e.g., periodic review).
• Coordinate qualification activities and keep equipment and utility systems in a validated state.
• Develop or qualify approaches and equipment family strategies.
• Assist in URS and QRAES development for equipment and automated systems.
• Develop and approve C&Q/Validation Plans, FAT, SAT, IV/FTs, QRAES, IOQs, PQs for Vial, Syringe filling, formulation, inspection and clean utility areas in line with GMPs and regulatory standards.
• Assist in assessment of project change controls ensuring Validation standards and requirements are met.
• Liaise with Engineering, Commissioning, PD, external vendors to ensure quality by design principles are followed.
• Improve equipment validation lifecycle process and ensure ongoing compliance with regulations.
• Participate in regulatory inspections, filings and RTQs.
• Update and maintain SOPs in accordance with site and corporate requirements.
• Take ownership for quality compliance in all activities you are responsible for.
• Ensure site change control procedures are adhered to.

Skills

Validation lifecycle

GMP compliance

Risk-based approach

Technical validation

Education

Engineering or science degree

Job description

Senior Equipment Engineer Onsite RK5643 Contract 12 months Dublin Were currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Dublin. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.

Key Responsibilities

• Provide expert technical validation support to meet site objectives, comprising of the full validation lifecycles process from initial design through qualification to validation maintenance (eg. Periodic review)
• Coordinates the qualification activities and maintain Equipment and utility systems in a validated state
• Development or qualification approaches and equipment family strategies
• Assist in the development of User Requirement Specifications (URSs) and Quality Risk Assessment for Equipment and Automated Systems (QRAES)
• Development and approval of C&Q / Validation Plans, FAT, SAT IV/FTs, QRAES, IOQs, PQs etc. for the Vial and Syringe filling, formulation, inspection and clean utility areas in line with GMPs, regulatory requirements and corporate standards.
• Assist in assessment of project change controls ensuring Validation standards & requirements are met.
• Liaise with Engineering, Commissioning and Qualification, manufacturing, planning and PD and external vendors regarding equipment User Requirement Specifications, Factory Acceptance Tests to ensure the quality by design principles are being followed.
• Assist in the development and improvements of the equipment validation lifecycle process while ensuring continued compliance to all necessary regulations.
• Participate in regulatory inspections, regulatory filings and RTQs (response to questions).
• Update and maintain Standard Operating Procedures (SOP's) in accordance with site and corporate requirements.
• Take ownership for quality compliance in all activities you are responsible for,
• Ensuring approaches are aligned with current guidelines (ICH/ASTM)
• Ensure the site change control procedure is adhered to.

Education and Experience

• 6+ years experience in Science, Engineering or Validation, Commissioning and Qualification Management
• Technical qualification at third level or equivalent in Engineering or science.
• Extensive knowledge and demonstrated experience managing Commissioning and Qualification for Pharmaceutical / Biotechnology projects
• Strong understanding of a risk-based approach to commissioning and qualification within the biotechnology industry
• Experience of sterile / biotech equipment within the pharmaceutical industry is preferred.
• Experience qualifying filling, formulation and utility systems within the sterile manufacturing environment of drug product.