Process Specialist

⚗️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 supplier’s 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:

• a company car & fuel card
• hospitalization & group insurance
• others

• Invest in your development: our talent manager is committed to help you reach your full potential:

• training and assessment opportunities to fully develop your potential and expand your expertise
• career opportunities

• Access to our fun and learning events that we organise throughout the year, the backbone of our company culture:

• Afterworks
• Monthly teambuildings
• Yearly ski trip

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 www.sisu.be for more information.