Project engineer Capex - Life Sciences - M/V/X

Project Engineering & Control

- Prepare cost estimations & conduct Value Improvement Reviews
- Perform project risk assessments
- Prepare project initiation documents (Business Requirements – PBR, Work Breakdown Structure – WBS, Cost Breakdown Structure – CBS, Project Scope Statement – PSS)
- Develop project sourcing strategy
- Identify technical solutions
- Draft project quality plan
- Prepare project procurement plan, manage tenders, and purchasing
- Manage project HSE and conduct safety reviews
- Conduct project reviews (e.g., Technical Quality Review – TQR, constructability)
- Develop commissioning plan/strategy
- Set up Project Change Management and handle changes
- Submit legal permits for the project
- Prepare equipment specifications and system requirements (e.g., - - User Requirements Specification)
- Develop project execution plan (e.g., construction phase)
- Prepare/execute project health & safety risk assessments (equipment/process)
- Prepare functional specifications
- Draft, review, and approve drawings, lists, schedules, diagrams, layouts, calculations, and datasheet
- Issue orders/contracts based on technical specs and bill of quantities

 
Monitor and manage project vendors/contractors/third parties
Develop test specification/plans for commissioning & qualification
Execute construction management and installation supervision
Perform FAT/SAT/inspections of new equipment
Implement and monitor safety and inspection plans for contractors
Execute work orders according to procedural instructions
Carry out commissioning activities
Manage project deficiencies and deviations
Develop and execute the project strategy based on customer needs (cost, schedule, functionality, quality

Re)Qualification

Develop qualification plan
Perform GMP risk assessments (incl. Sensor Risk Assessment – SRA)
Create DQ, IQ, and OQ protocols
Execute DQ, IQ, and OQ
Draft DQ, IQ, and OQ reports
Provide technical troubleshooting during PQ and validation

Relevant Experience:

5 years of technical experience, including 2 years in capital investment projects in the chemical or pharmaceutical industry
Leadership experience managing external resources
Proven project management skills, including contract management and project control
Broad interdisciplinary knowledge
Extensive HSE and GxP/QA knowledge

Education & Qualifications:

Degree in Engineering (Dipl. Ing. / M.Sc. / B.Sc.) or equivalent

Languages:

Fluent in English and proficient in the local language