Featured Opportunities in Life Sciences & Healthcare

Title: Senior Principal Validation Engineer

Reports to: Director of Validation

Visa Sponsorship Available?: Yes

Permanent or Contract?: Permanent

Relocation Assistance?: Yes - $25,000 (pre-tax) deposited after clearing onboarding

Description:

This role leads validation efforts across a manufacturing site, overseeing daily activities, projects, and overall validation strategy. The position is responsible for ensuring equipment, systems, and processes remain compliant, properly qualified, and fully documented. This includes managing validation programs, reviewing change controls, maintaining validated equipment, and updating key documentation such as Validation Master Plans. The role also works cross-functionally with engineering, facilities, and project teams to support new product introductions, equipment requalification, and overall plant readiness. In addition, this person serves as the primary validation contact for customers, vendors, and regulatory agencies, supporting audits and ensuring alignment on compliance expectations. 

The Senior Principal Validation Engineer takes a hands-on leadership role in executing and overseeing validation activities, including risk assessments and IQ/OQ/PQ protocols for equipment, systems, and utilities. This includes developing validation protocols and reports, supporting audits, guiding contractors and team members, and ensuring all work meets cGMP and GDP standards. The role also involves coordinating validation timelines across projects, supporting technology transfers, and providing technical input on facility upgrades and process improvements.

Requirements: 

• Candidates should have a bachelor’s degree or master’s degree in engineering, science, or a related field, along with significant experience in pharmaceutical validation or sterile/aseptic manufacturing environments. 
• Strong experience with validation documentation, technical writing, and regulatory requirements (FDA and EU) is required.
• Hands-on experience with equipment and systems such as WFI, clean steam, lyophilizers, autoclaves, and validation tools (e.g., temperature mapping) is expected, along with a solid understanding of media fills and cleaning validation. 
• Candidates must be comfortable working in regulated environments and able to support audits, compliance activities, and cross-functional teams.