Job Summary:
12-month contract role with a major pharmaceutical company in Wicklow, offering the opportunity to play a key role in high-impact GMP projects, new product introductions and state-of-the-art manufacturing and packaging upgrades. If keen to learn more about this opportunity or similar roles kicking off in Q1, please reach out today for a confidential conversation.
Responsibilities:
- Prepare, review and approve cGMP commissioning and validation documentation for equipment, facilities, utilities, computerized systems, automation packages, and manufacturing and packaging processes.
- Provide validation and quality input across all project phases, including design, commissioning, qualification and handover.
- Execute and manage commissioning and validation activities, including the documentation, investigation, resolution and closure of punch list items and validation deviations.
- Initiate, manage and approve GMP change controls, risk assessments and validation-related quality documentation.
- Plan, manage and deliver validation schedules and timelines in alignment with site and project milestones.
- Ensure site-wide compliance with current regulatory requirements, including FDA cGMPs, data integrity and applicable validation standards.
- Compile, review and approve GMP documentation such as VMPs, URSs, DQs, FATs, IOQs, OQs, PQs, and validation reports.
- Lead and support cleaning validation activities across manufacturing and packaging operations.
- Evaluate, qualify and manage vendors and service providers to ensure compliance with cGMP and validation requirements.
- Provide oversight and support during vendor-led commissioning and qualification activities.
- Support new product introductions (NPI) and equipment upgrades within processing and packaging environments.
- Participate in and support major capital projects, including high-speed capsule filling equipment, blister line upgrades, utility upgrades and general asset care initiatives.
- Collaborate cross-functionally with Engineering, Manufacturing, Quality, Regulatory and EHS teams to deliver project objectives to an acceptable GMP standard.
- Promote a strong culture of quality, compliance and continuous improvement across the site.
- Apply risk-based decision making to manage priorities, resolve complex issues and ensure project and quality objectives are met.
- Demonstrate strong technical writing, attention to detail and effective verbal communication skills.
- Contribute to training, mentoring and knowledge-sharing to enhance GMP and validation capability within the organization.
Requirements:
- Bachelor’s degree preferably in Engineering, Science or other technical field (engineering degree preferred).
- Minimum of 5 years related experience in pharmaceutical manufacturing environment, validation, operations, engineering, or any combination thereof.
- Experience in Production and or Packaging processes and control systems, process equipment, facilities and utilities.
- Experience in technical writing of GMP related documentation
- Experience in risk assessments drafting and risk based approach test protocol creation in relation to validation activities.
- Experience of Electronic Documentation Management Systems (KNEAT, VEEVA, TRACKWISE)
- Strong attention to detail and accuracy.
- Strong interpersonal skills to support relationships with a number of stakeholders
- Past experience writing, reviewing and executing validation documentation (Validation Plan, FAT, SAT, IQ, OQ, PQ, RTM, summary report) an advantage
- Experience in a large company environment
- High leadership skillset
- High strategic thinking
- Quality and EHS awareness
#LI-PC2