CQV Doc Prep Lead- BioPharma-Hybrid/Remote

PES is an international services company providing Project Management, Construction Management, Commissioning & Qualification and Automation services to our clients in the pharmaceutical, nutritional and related sectors.

With offices across Europe, Asia and US, our core focus is on consistently delivering high quality outcomes for our multinational clients.

This focus and our people's experience in delivering consistent quality results for our clients over the past 20 years have been key to our success to date.

We are currently looking for CQV Doc Prep Lead to join us permanently to help us deliver various projects in the Life Sciences Industry.

Key Responsibilities:

• Develop and review CQV lifecycle documents, including URS, DQ summaries (as applicable), IQ, OQ, and PQ protocols and reports
• Author validation protocols and reports in accordance with site procedures and regulatory expectations
• Ensure proper document formatting, version control, and traceability throughout the document lifecycle
• Coordinate with CQV engineers, QA, and project stakeholders to gather and verify technical inputs
• Support document revisions, approvals, and close-out activities to meet project timelines
• Ensure documentation aligns with GMP (EU/FDA), Annex 15, ASTM E2500, and site-specific quality systems
• Maintain audit-ready documentation by ensuring completeness, accuracy, and compliance
• Track documentation status and support timely delivery of validation deliverables
• Assist in risk assessments, traceability matrices (RTM), and change control documentation
• Collaborate with cross-functional teams including Engineering, QA, Automation, and external vendors
• Must be willing to travel to Malaysia occasionally

If you'd like to find out about this opportunity or any other opportunity, please forward your CV to Nelson Anthony([email protected]).

If you would like to find out about the latest Jobs and Projects we are involved in then do follow us on LinkedIn: https://www.linkedin.com/company/processengineeringspecialists/mycompany/

PES International operates as an equal opportunity employer. No terminology in this advert is intended to discriminate on the grounds of age, race, religion, sexual orientation or any other factors with no bearing to employment skills and we confirm that we are happy to accept applications from persons of any background for this role.