Project Engineer

Occupli

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profile Job Location:

Dundalk - Ireland

profile Monthly Salary: Not Disclosed
profile Experience Required: 5years
Posted on: 16 hours ago
Vacancies: 1 Vacancy

Job Summary

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...
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Company Industry

IT Services and IT Consulting

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