Job description Job Description

We are seeking a highly skilled and experienced Validation Engineer at Amaris Consulting. This is an opportunity to join an integrated project team where you will drive the Performance Qualification (PQ) preparation and execution activities of the project. The role ensures that all tasks are completed in accordance with system requirements, specifications, quality attributes and project procedures/guidelines.

• Scope: Clean Utilities (water, gas, air, steam, decontamination station)

• Facility Environmental Monitoring (classified area PQ)

• Temperature control units management (fridge, freezer, incubator etc.)

• Cleaning process oversight including Parts Washer cleaning cycle

• Sterilisation process management including Autoclave sterilisation cycle

• PQ strategy/protocol drafting following approved PQ VMP guidelines

• Assisting in Quality Risk Assessment development for PQ

• PQ verification deliverables driving; protocol execution; deviation investigation and resolution coordination

• C&Q status planning tracking & reporting along with risk/issues identification

This position is based in Belgium under an Undetermined Duration Contract type job arrangement.

About You

The ideal candidate for this role would be someone who has 7-10 years of experience as a Validation Engineer or similar roles within the industry. As an experienced Validation Engineer/PQ Specialist; you will act as C&Q Subject Matter Expert providing guidance to stakeholders on all aspects related to performance qualification from strategy development to summary report approval ensuring compliance with cGMP regulations.

• Proven experience in driving PQ preparation and execution activities

• Expertise in Clean Utilities, Facility Environmental Monitoring, Temperature control units management

• Demonstrated ability to draft PQ strategy/protocol(s) following approved guidelines

• Experience with Quality Risk Assessment development for PQ

• Adept at managing deviation investigation and resolution during execution activities

• Familiarity with change controls related to technical modifications approval coordination

• We are looking for a proactive individual who can take appropriate corrective actions as required to ensure deadlines and milestones are achieved. You should be able to establish and monitor validation KPIs while also reviewing handovers of equipment/systems from suppliers or other project stakeholders.

  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.