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About
Occupli are delighted to partner with our client a Pharmaceutical Multinational.
Have you got the right qualifications and skills for this job Find out below, and hit apply to be considered.
Contract: 24 months (initial 12-month)
Location: Eastern & Midland Region, Ireland (on-site)
Role Summary:
Serve as Occupli’s client-representative (embedded) within the Global Engineering Team, providing project engineering support for commissioning and qualification of a drug substance / drug product manufacturing facility. You will help manage cross-functional teams to deliver key C&Q milestones.
Key Responsibilities:
- Develop and maintain project schedules, work plans, and cost-tracking for equipment and capital.
- Coordinate across stakeholders including engineering, validation, quality, operations, and vendors.
- Lead installation, start-up, and testing through Operational Qualification (OQ).
- Support readiness for post-OQ phases (PQ, PPQ), ensuring design and validation deliverables reflect site and business requirements.
- Monitor project progress, costs, and risks; produce tiered status reporting.
- Engage with cross-functional experts, SMEs, and vendor partners to ensure alignment.
- Assist in regulatory and validation documentation, including CAPAs and risk assessments.
- Drive continuous improvement in C&Q execution and handover processes.
Requirements:
- Bachelor’s or Master’s degree in Engineering (Mechanical, Process, Chemical, etc.).
- Minimum 6 years’ experience in a commissioning / qualification / validation role — ideally in a sterile or aseptic manufacturing environment.
- Experience writing and executing IQ/OQ (and preferably PQ) protocols.
- Strong project coordination, communication and stakeholder engagement skills.
- Demonstrated ability to collaborate cross-functionally and work as part of a team.
Desirable (but not essential):
- Knowledge of GMP, risk-based validation (e.g. FMEA), and ISPE / GAMP frameworks.
- Experience with FAT / SAT, vendor management, and commissioning change control.
Why Work With Us / Benefits:
- Work on a high-impact project in a leading pharmaceutical manufacturing facility.
- Be part of an international engineering team and contribute to critical qualification phases.
- Gain contract-based flexibility with the opportunity to make a measurable difference. xcfaprz
- Opportunity to deepen your expertise in pharma commissioning & validation.
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Languages
- English
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