Senior Cleaning & Equipment Validation Lead

BioTalent; Portsmouth (NH); On-site; USD 120,000 - 180,000; Full time

Job summary

BioTalent in Portsmouth, NH seeks a highly experienced Cleaning Validation & Equipment Validation Engineer to build core validation programs from the ground up in a GMP biopharma setting. You will author SOPs, create validation documentation, and drive sustainable processes with minimal direction.

The role requires 8+ years in pharmaceutical validation, hands-on experience with cleaning validation, CIP/COP/SIP systems, IQ/OQ/PQ, and direct Kneat usage.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, or a related technical discipline.
• 8+ years of pharmaceutical, biotechnology, or regulated manufacturing validation experience.
• Demonstrated experience establishing cleaning validation programs from the ground up.
• Direct experience with Kneat is required.

Responsibilities

• Design, develop, and implement cleaning validation and equipment validation programs with limited oversight.
• Author SOPs, validation plans, protocols, and reports.
• Lead qualification and validation activities for autoclaves, parts washers, and cold storage equipment.
• Develop temperature mapping procedures and support mapping studies.
• Drive validation activities related to equipment changes, process improvements, deviations, CAPAs, and change controls.

Skills

Engineering

GMP

SOP Writing

Validation

Independent work

Education

Bachelor's degree in Engineering/Life Sciences

Tools

Kneat

Ellab

Job description

BioTalent in Portsmouth, NH seeks a highly experienced Cleaning Validation & Equipment Validation Engineer to build core validation programs from the ground up in a GMP biopharma setting. You will author SOPs, create validation documentation, and drive sustainable processes with minimal direction.

The role requires 8+ years in pharmaceutical validation, hands-on experience with cleaning validation, CIP/COP/SIP systems, IQ/OQ/PQ, and direct Kneat usage.