Title: Cleaning Validation Consultant / Principal Validation Engineer
Location: Milford, MA
Duration: 12-Month Contract
Pay Rate: $60-65/Hr On W2
Position Summary:
We are seeking an experienced Cleaning Validation Consultant to support both new product introductions (NPI) and ongoing lifecycle management of validated manufacturing equipment within a GMP pharmaceutical/biotech environment.
This individual will serve as the subject matter expert for cleaning validation activities, performing risk assessments, determining the impact of process or product changes on existing validated systems, and developing and executing validation strategies as needed. The consultant will work closely with Engineering, Manufacturing, Quality, Validation, and Technical Operations teams to ensure equipment remains in a validated state throughout its lifecycle.
The ideal candidate combines strong technical expertise in cleaning validation with hands-on execution experience and the ability to lead cross-functional projects in a regulated manufacturing environment.
Key Responsibilities:
Cleaning Validation Leadership
Serve as the primary SME for cleaning validation activities across manufacturing operations.
Evaluate the impact of new product introductions on existing validated equipment and cleaning processes.
Conduct risk assessments to determine whether existing cleaning validation programs remain applicable or require modification.
Develop cleaning validation strategies and protocols based on risk assessment outcomes.
Author, review, approve, and execute cleaning validation documentation including:
Risk Assessments
Validation Master Plans
Protocols
Reports
Deviations
Change Controls
New Product Introductions (NPI)
Support introduction of new products utilizing existing manufacturing equipment.
Assess product-related risks that may affect current cleaning validation programs.
Determine requirements for cleaning re-validation activities.
Design and execute cleaning validation studies when required.
Continued Process Verification / Lifecycle Management
Support Stage 3 Continued Process Verification and ongoing validated-state maintenance activities.
Evaluate equipment, process, and product changes for potential impact on validated cleaning procedures.
Perform risk assessments and execute validation activities associated with equipment or process modifications.
Ensure validated systems remain compliant with regulatory expectations and internal quality requirements.
Validation Lifecycle Activities
Support commissioning, qualification, and validation activities throughout the equipment lifecycle.
Develop and execute validation documentation including:
Design Qualification (DQ)
Factory Acceptance Testing (FAT)
Site Acceptance Testing (SAT)
Installation Qualification (IQ)
Operational Qualification (OQ)
Performance Qualification (PQ)
Maintain validated state for manufacturing, quality control, and supply chain equipment.
Project & Compliance Support
Lead or support multiple validation projects simultaneously.
Collaborate with Engineering, Quality Assurance, Manufacturing, and Technical Operations teams.
Drive implementation of risk-based validation approaches aligned with ASTM E2500 principles.
Support inspections, audits, and regulatory submissions as required.
Required Qualifications:
Bachelor's degree in Engineering, Life Sciences, Chemistry, Biology, Chemical Engineering, Mechanical Engineering, or related scientific discipline.
7+ years of validation experience within pharmaceutical, biotechnology, CDMO, or regulated manufacturing environments.
Strong hands-on experience with Cleaning Validation in GMP manufacturing facilities.
Demonstrated experience performing risk assessments and developing cleaning validation strategies.
Experience supporting New Product Introductions (NPI).
Experience evaluating changes to validated equipment and determining revalidation requirements.
Strong technical writing skills with proven ability to author validation protocols and reports.
Thorough understanding of:
FDA regulations
GMP requirements
Validation lifecycle principles
Change control processes
Risk management methodologies
Ability to manage multiple projects and work cross-functionally with diverse stakeholders.
Preferred Qualifications
Experience applying ASTM E2500 risk-based validation principles.
Previous experience in a CDMO environment.
Experience with lifecycle validation and Continued Process Verification (Stage 3).
Experience with disposable/single-use manufacturing technologies.
Previous leadership or project management experience supporting CAPEX and OPEX initiatives.
Salary:
The hourly rate for this position is $60 $65/Hr on W2, depending on experience and qualifications.
Benefits:
Eligible employees may have access to benefits offered by Novozen Healthcare LLC in accordance with the applicable benefit plans and eligibility requirements.
Equal Employment Opportunity:
Novozen Healthcare LLC is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, disability, genetic information, veteran status, or any other characteristic protected by applicable federal, state, or local law.
Background Check:
Background checks may be conducted in accordance with applicable law.