Validation Engineer - Flow Cytometer

ELIQUENT Life Sciences is the leading global consulting firm providing solutions to life science companies researching, developing, and manufacturing innovative products to serve patients and respond to public health challenges around the world. ELIQUENT is committed to serving clients’ needs with extensive expertise, unwavering integrity, and strategic insight in a manner that supports availability of safe, effective, and high-quality drugs, biologics, and medical devices. For more information, please visit our website at eliquent.com.

We are seeking a Validation Specialist to support the Lifecycle Asset Management (LCAM) replacement of one (1) BD FACS Canto Flow Cytometer. This role will be responsible for both the qualification of a new flow cytometry system and the decommissioning of the existing system. The position requires close coordination with cross-functional teams including Facilities, System Owners, Quality, and external vendors to ensure full compliance with regulatory standards and internal procedures.

Key Responsibilities:

New System Commissioning & Qualification:

• Author and revise qualification protocols (e.g., IOQ), including managing dry runs and routing documents via Veeva Vault.
• Coordinate with Enterprise Asset Management, Facilities, and System Owners to ensure proper asset induction prior to qualification.
• Support vendor-led qualification activities including:
• Escorting vendors on site
• Providing access, training, and necessary materials
• Printer and systems support
• Execute qualification protocol (paper-based execution with subsequent electronic upload).
• Manage submission of protocols to review and approval workflows, reconcile reviewer comments.
• Draft and route the Validation Summary Report for final approvals.

Old System Decommissioning:

• Coordinate and support decommissioning efforts, including:
• Verification of final calibration and maintenance
• Oversight of decontamination and cleaning processes
• Compile and complete the Decommissioning Periodic Review Report:
• Review of work orders, quality records, and historical documentation

Hourly Rate: $60 to $70/hr

• Bachelor’s degree in Engineering, Life Sciences, or related field.
• 3+ years of experience in equipment validation or lifecycle asset management in a GMP-regulated environment (biotech/pharma preferred).
• Familiarity with GxP systems and equipment qualification practices (IQ/OQ/PQ).
• Experience using Veeva Vault or similar document management systems.
• Strong project coordination and communication skills.
• Ability to work independently with cross-functional teams and external vendors.
• Experience with flow cytometry equipment, particularly BD FACS Canto.
• Previous experience supporting equipment decommissioning and validation documentation.
• Understanding of Enterprise Asset Management (EAM) systems and processes.

What We Offer:

• Competitive Compensation: Attractive salary and comprehensive benefits package for full-time and part-time employees, including health, dental, vision, and life insurance, a 401(k) plan with employer match, a generous paid time off policy, and additional perks. Compensation is commensurate with professional experience.
• Career Development: Opportunities for professional growth and advancement within a supportive and innovative environment.
• Work-Life Balance: Flexible work arrangements and a commitment to maintaining a healthy work-life balance.

Eliquent Life Sciences is proud to be an Equal Opportunity Employer, committed to employee diversity.