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

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