Engineering Validation Associate

Desired Skills: GMP Compliance,CQV Execution,Cross-Functional Collaboration

PE Global is currently recruiting for a Engineering Validation Technician for a leading multi-national Biotech client based in Cork.

This is an initial 12-month contract position working on days.

ROLE:

• In collaboration with plant support functions, assist with planning, set up and implementation of Analytical Instrument Qualification, Facilities, Utilities, Equipment (FUE) Qualification and Process Validation programs.
• Execute (protocol generation, execution, and final package preparation) Validation activities related to the various Validation disciplines e.g. FUE Qualification, CSV, New Product Introductions and Change Control.
• Develop validation plans for specific system implementation projects.
• Support the establishment of site validation policies, through development, generation and implementation of site validation master plans, guideline documents and standard operating procedures.
• Prepare and track to completion any assigned change requests, deviations, quality events and associated CAPAs.
• Develop and demonstrate an active approach to safety, industrial hygiene, environmental and regulatory compliance.
• Assist with preparation of regulatory filings and participation during regulatory inspections/partner audits.
• Maintain current knowledge of industry standards and regulatory requirements for products developed or manufactured by client, validation techniques/approaches and systems utilized at site
• Lead and represent validation in multi-departmental meetings and project teams.
• Identifies and implements improvements to the Engineering Validation systems.
• Coordinate validation activities involving cross-functional, multi-departmental teams including: Manufacturing, Process Sciences, Process Development, Quality Control, Quality Assurance, Regulatory Affairs, and others.
• Other duties as assigned.

REQUIREMENTS:

• Bachelor’s degree (Level 8 or equivalent) in Engineering, Biotechnology, Biochemistry, Pharmaceutical Science, Chemical Engineering, or a related life-sciences discipline, providing a strong foundation in manufacturing processes, validation principles, data analysis, and regulatory compliance.
• Minimum 5 years’ experience in Engineering Validation within a GxP-regulated environment. Proven hands-on experience executing validation activities in biopharmaceutical, pharmaceutical, biotechnology, or medical device manufacturing, including equipment, utilities, facilities, laboratory systems, and/or process validation.
• Strong background in Commissioning, Qualification, and Validation (CQV). Demonstrated experience generating and executing validation protocols (IQ/OQ/PQ), preparing final validation packages, and supporting FUE qualification, CSV, New Product Introductions (NPI), and Change Control activities.
• Solid understanding of regulatory and compliance requirements. In-depth working knowledge of cGMP, GxP, FDA, EMA, ICH, and data integrity requirements, with experience supporting regulatory inspections, partner audits, and preparation of regulatory submission documentation.
• Experience managing deviations, change controls, and CAPAs Ability to prepare, track, and close change requests, deviations, quality events, and CAPAs in collaboration with Quality and cross-functional stakeholders, ensuring compliance and timely resolution.
• Strong cross-functional collaboration and technical leadership skills. Experience leading or representing validation in multi-department project teams, coordinating activities across Manufacturing, Quality, Process Sciences, Engineering, IT/CSV, and Regulatory Affairs, with the confidence to drive validation deliverables to completion.

Interested candidates should submit an updated CV.

Please click the link below to apply, call Seán on +353 86 3514962 or alternatively send an up-to-date CV to sean.molloy@peglobal.net 

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***