Role: Project Engineer C&Q (Commissioning & Qualification)
Contract: 24 months (initial 12-month)
Location: Eastern & Midland Region Ireland (on-site)
Role Summary:
Serve as Occuplis client-representative 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
Requirements:
- Bachelors or Masters 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.
- Opportunity to deepen your expertise in pharma commissioning & validation.
Required Skills:
Requirements: Bachelors or Masters 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. Opportunity to deepen your expertise in pharma commissioning & validation.
Required Education:
Bachelors degree (or higher) in a relevant discipline such as Chemistry Biology Engineering or Supply Chain.
Role: Project Engineer C&Q (Commissioning & Qualification) Contract: 24 months (initial 12-month) Location: Eastern & Midland Region Ireland (on-site) Role Summary: Serve as Occuplis client-representative within the Global Engineering Team providing project engineering support for commissioning and...
Role: Project Engineer C&Q (Commissioning & Qualification)
Contract: 24 months (initial 12-month)
Location: Eastern & Midland Region Ireland (on-site)
Role Summary:
Serve as Occuplis client-representative 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
Requirements:
- Bachelors or Masters 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.
- Opportunity to deepen your expertise in pharma commissioning & validation.
Required Skills:
Requirements: Bachelors or Masters 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. Opportunity to deepen your expertise in pharma commissioning & validation.
Required Education:
Bachelors degree (or higher) in a relevant discipline such as Chemistry Biology Engineering or Supply Chain.
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