Senior validation engineer (PQ)
Brabant Wallon – contracting
Our partner is looking for a Senior validation engineer to strengthen its team. This international company is well-known for its research, development, and marketing of pharmaceutical and vaccines.
What are your responsibilities?
- Act as C&Q Subject Matter Expert and Compliance for PQ. Ability to provide guidance and work with project stakeholders (technical, QA, validation, QC) and suppliers in all PQ activities from strategy development to PQ protocol and acceptance criteria definition and execution and to summary report approval. to meet cGMP and quality requirements on time and on budget to ensure that programs are compliant with Regulatory Authorities’ expectations and related SOPs.
- Draft PQ strategy/protocol(s) and testing rationals following approved PQ VMP, collect input from stakeholders, coordinate review and approval cycle in a timely manner.
- Assist/ facilitate in the development of specific Quality Risk Assessment for PQ.
- Drive PQ verification deliverables, cycle development, protocol execution, deviation investigation and resolution for problems and issues encountered during execution activities. Write and coordinate approval of change controls related to technical modifications.
- Responsible for the Planning, Tracking and Reporting of C&Q status and risks/issues for the selected system(s). Take appropriate corrective actions as required to ensure deadlines and milestones are achieved.
- Establish and monitor validation KPIs.
- Review handover of equipment / systems from suppliers and or other project stakeholders.
Who are you ?
- More than 5 years of experience with PQ phase having led and managed validation projects, including sterile manufacturing.
- Must have experience of working on projects; project management experience. We need someone who understands and knows what to do but not a PM expert.
- Knowledge of safety, GMP and environmental regulatory requirements.
- Expert in reviewing and writing technical reports.
- EN is a must have
- Ability to work with other persons – team spirit.
- Homeworking : authorized, but must remain flexible according to project needs.
What can you expect ?
Jefferson Wells offers you a permanent contract as consultant with an attractive salary package and will give you access to trainings in technical matters and soft skills. We will be your career partner for each step along the way.
