Support, counsel and coordinate commissioning activities of direct impact systems.
Ensure commissioning activities are as per CMP.
Review and approve commissioning protocols.
Establish and execute validation protocols including IQ, OQ, PQ and/or PV for multi-
disciplinary systems, including upstream biotech, downstream biotech, lab equipment, clean utilities, clean rooms and CIP/SIP validation, process validation and CSV.
Supervise /manage schedule for validation activities such as GMP status, equipment
qualification, audits and CAPAs.
Ensure proper qualification of systems with adherence to VMP and Quality.
Conduct GMP and validation SOPs class room training for all staff from technicians to
Act as the main point of contact for project engineering change management and deviations,
including reviewing and approving project change controls and deviations.
Complete weekly PCM status reports for senior management.
Ensure proper document management in KNEAT, and support the uploading of validation
documents in KNEAT.
Review hand over documents during project close out.
Perform business development duties when needed, including presentation to clients,
outsourcing personnel, managing employees and managing company budget.
Perform other duties as assigned by manager.
Academic degree in Engineering.
Minimum 12 – 15 years’ experience in a pharmaceutical GMP environment and knowledge in
Experience in training people.
Experience in Business Development
Extended knowledge in EU and US GMP regulations.
Knowledge in Good Documentation Practices in the pharmaceutical industry with hands on
experience in KNEAT software.
Ability to provide immediate solutions to engineering changes and challenges.
Experience in defining vendor scope and managing.
Excellent decision-making skills and can work under pressure.
Preferred candidates shall have experience in validation for the following systems:
manufacturing equipment for both upstream and downstream biotech, CIP, SIP, clean rooms,
laboratory equipment, and process validation.
Languages: Should be fluent in written and spoken English, and have at least basic German