Job description Job Description

We are seeking an experienced Process Engineer-DSP Specialist to join our team at Amaris Consulting. This is a full-time position with an undetermined duration contract, based in Belgium. The ideal candidate will have 7-10 years of relevant experience and be well-versed in large scale EPCM Projects within the pharmaceutical industry.

• In-depth technical experience in a regulated environment with knowledge of gene therapy, biologicals, pharmaceutical and engineering operations.

• Ability to lead the DSP team from End of detailed Design with Automation document to the end of the first product run.

• Proficiency in interpreting and setting up P&ID (Piping & Instrumentation Diagrams), FS (Functional specification) and PFD (Process Flow Diagrams).

• Adeptness at acting as a technical process expert during HAZOP/QRA/FMEA sessions.

• Familiarity with qualification & validation approaches such as ASTM E2500 is highly desirable.

• Solid understanding of cGMP/GLP regulations, ICH guidelines, FDA CMC requirements, ISPE standards and PDA Guidance Documents preferred.

• Demonstrated ability to provide Engineering offices with applicable standards while reviewing PFD's and P&ID's.

The successful candidate will also participate actively in commissioning, qualification & verification processes including design review/verification alongside the Engineering office/CQV team; leading/participating in FAT/SAT for equipment within scope; challenging technical solutions proposed by Engineering Office; integrating safety/sustainability/green assessment into designs; following-up/challenging work done by engineering office etc. We look forward to welcoming you on board!

About You

You are a seasoned professional who has spent between 7-10 years working on large scale EPCM Projects in the pharmaceutical industry. You are comfortable working in a regulated environment and have an extensive knowledge of gene therapy, biologicals, pharmaceutical and engineering operations.

• You are adept at leading teams through complex projects from detailed design to product run completion.

• Your technical expertise allows you to interpret P&ID's, FS's and PFD's with ease as well as conduct HAZOP/QRA/FMEA sessions effectively.

• You understand qualification & validation approaches like ASTM E2500 thoroughly and can apply them appropriately within your work context.

• Knowledge of cGMP/GLP regulations, ICH guidelines, FDA CMC requirements, ISPE standards and PDA Guidance Documents is second nature to you.

In addition to these hard skills, we value candidates who demonstrate strong communication abilities; possess excellent problem-solving capabilities; show initiative in challenging conventional solutions; prioritize safety/sustainability/green assessment when designing processes etc. If this sounds like you then we would love for you to join our team!

What can you expect?

Amaris Consulting is proud to be an equal-opportunity workplace. We are committed to promoting diversity within the workforce and creating an inclusive working environment. For this purpose, we welcome applications from all qualified candidates regardless of gender, sexual orientation, race, ethnicity, beliefs, age, marital status, disability or other characteristics.