Cleaning Validation Engineer

Title : Cleaning Validation Engineer

Location: Milford, MA
Employment Type: Contract W2
Duration: 12 Months
Rate: $56 $59/hr W2
Industry: Pharmaceutical / Biotechnology

About the Role

We are seeking an experienced Cleaning Validation Consultant / Principal Validation Engineer to support New Product Introductions (NPI) and lifecycle management of validated manufacturing equipment in a GMP-regulated pharmaceutical/biotechnology environment.

The role will serve as a subject matter expert for cleaning validation, risk assessments, validation strategies, and maintaining equipment in a validated state throughout its lifecycle.

Responsibilities

• Lead cleaning validation activities across GMP manufacturing operations.

• Evaluate the impact of NPI, process changes, and product changes on existing cleaning validation programs.

• Perform risk assessments and determine cleaning revalidation requirements.

• Develop, review, and execute cleaning validation strategies, protocols, and reports.

• Author and review validation documentation, including risk assessments, validation plans, protocols, reports, deviations, and change controls.

• Support cleaning validation studies and maintain validated manufacturing systems.

• Support Stage 3 Continued Process Verification and lifecycle validation activities.

• Support DQ, FAT, SAT, IQ, OQ, and PQ activities throughout the equipment lifecycle.

• Evaluate equipment and process modifications for validation impact.

• Apply risk-based validation principles aligned with ASTM E2500.

• Collaborate with Engineering, Quality, Manufacturing, Validation, and Technical Operations teams.

• Support audits, inspections, and regulatory activities as required.

Required Qualifications

• Bachelor's degree in Engineering, Life Sciences, Chemistry, Biology, or a related scientific discipline.

• 7+ years of validation experience in pharmaceutical, biotechnology, CDMO, or regulated manufacturing environments.

• Strong hands-on Cleaning Validation experience in GMP manufacturing facilities.

• Experience with risk assessments and cleaning validation strategies.

• Experience supporting New Product Introductions (NPI).

• Experience evaluating changes to validated equipment and determining revalidation requirements.

• Strong technical writing skills with experience authoring validation protocols and reports.

• Strong knowledge of GMP, FDA regulations, validation lifecycle principles, change control, and risk management.

• Ability to manage multiple projects and work effectively with cross-functional teams.

Preferred Qualifications

• ASTM E2500 risk-based validation experience.

• CDMO experience.

• Stage 3 Continued Process Verification and lifecycle validation experience.

• Experience with disposable/single-use manufacturing technologies.

• Project or technical leadership experience supporting CAPEX/OPEX initiatives.

Salary

The hourly rate for this position is $56 $59/hr W2 Max.

Benefits

This is a contract position and does not include employer-provided benefits.

Equal Opportunity Employer

We are an Equal Opportunity Employer. All qualified applicants will receive consideration without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

Background Check

Background checks may be conducted in accordance with applicable law.

Work Authorization

Applicants must be authorized to work in the United States.