Process engineers
Do you have a strong background in process engineering within the pharmaceutical industry? Are you experienced with GMP environments, EPCMV project execution, and bioprocess equipment ? Join our client and take part on high-impact technical projects from design through to final qualification.
TECHNICAL SKILLS
Project
Large experience with EPCMV (Engineering, Procurement and Construction Management & Validation) contracting models is mandatory
Ability to lead package in collaboration with suppliers from design to qualified status
Ability to lead & review PED (Pressure Equipment Directive) is a relevant asset
Ability to act as technical process expert during HAZOP (Hazard and Operability study) / QRA (Quality Risk Analysis) / FMEA
Knowledge in qualification & validation approaches (ASTM E2500) is highly important
Process
Good technical knowledge in bioprocess equipment (USP, DSP, media/buffer) and their applicability
Digital
Good knowledge in automated systems (Siemens PCS7) and understanding of IT security requirements (data integrity)
Quality
Strong knowledge of cGMP/GLP regulations, ICH, FDA CMC, ISPE and PDA Guidance Documents is preferred
Experience
In large and complex projects as well as both formal and informal leadership / coordination
BASIC & DETAILED DESIGN
Prepare Tender package and participate in discussions for supplier decision
Define the applicable standards/norms/engineering guidelines for the project
Provide suppliers with the applicable standards
Challenge technical solutions coming from suppliers
Integrate safety, sustainability and green assessment in the design
CONSTRUCTION
Track suppliers planning adherence for installation of systems. Progress report to be delivered to Process and Technical Lead
Organize quality checks on field before each technical milestone activity
Ensure good communication with other stakeholders linked to its activity
DOCUMENTATION
Update drawings in area of expertise
Write commissioning documentation and ensure that supplier documentation is acceptable for verification
Perform FAT/SAT activities in area of expertise
Support qualification phases after commissioning
Organize training of the final user in area of expertise & provide technical documentation to finalize the hand-over
YOUR PROFILE ;
Solid technical expertise in Upstream and Downstream Process
Good knowledge of automated systems
Fluent English is mandatory
French is highly desirable (French-speaking team environment)
Strong understanding of cGxP requirements
Able to manage smooth communication between all stakeholders (suppliers, users, project teams)
Soft skills
Team player with a rigorous and accountable mindset
Proactive and fully involved in project activities
Pragmatic approach to problem-solving
WHAT YOU''LL GET ;
A competitive salary package based on your experience with attractive fringe benefits such as:
Invest in your development: our talent manager is committed to help you reach your full potential:
Access to our fun and learning events that we organise throughout the year, the backbone of our company culture:
Catalay is part of Sisu Group, an ecosystem of human capital ventures, active across more than 15 industries. Joining Catalay means joining Sisu and having exclusive access to our vibrant network of talent professionals, clients, and projects. Check out for more information.