Validation Engineer

Direct message the job poster from Akkodis

Akkodis is Seeking a Validation Engineer for location of Mansfield MA. This is a 6-month contract Position. Ideally looking for a candidate with experience in medical device Manufacturing Industry

Pay Range: $50 - $60/hour;
The rate may be negotiable based on experience, education, geographic location, and other factors

Your Responsibilities will Include:

The Validation Engineer is responsible for the generation, execution, and documentation of validation activities with a primary focus on sterilization and microbiology for medical devices. This role ensures compliance with regulatory requirements and supports continuous process and quality improvements through cross-functional collaboration.

Key Responsibilities

• Generate, execute, and document validation plans, protocols (IQ/OQ/PQ), and final validation reports, with a strong focus on sterilization and microbiology.
• Perform statistical analysis of validation data to support conclusions and reports.
• Develop and implement Change Controls and Engineering Change Orders (ECOs).
• Create statistically based sampling plans for in-process inspections, final testing, and validation activities.
• Troubleshoot equipment and processes that do not perform as intended during validation runs.
• Identify, recommend, and support process and quality improvements as part of validation activities.
• Evaluate, investigate, and document non-conformance incidents and protocol deviations.
• Complete Non-Conformance and CAPA investigations and prepare comprehensive investigation reports.
• Maintain effective cross-functional collaboration with Manufacturing, Engineering, Quality Assurance, Regulatory, and Corporate teams.
• Participate in project teams involving internal departments, external vendors, and customers.
• Ensure all processes and activities comply with applicable regulatory and international standards, including FDA, ISO, OSHA, and EPA.
• Support the compilation and review of technical documentation for domestic and international regulatory submissions.
• Participate in internal and external audits, including FDA, Notified Body (BSI), and corporate audits.
• Perform other related duties as assigned.

Required Qualifications

• Strong knowledge of FDA, OSHA, EPA, GMP, and ISO requirements.
• Experience with Organizational Excellence methodologies, including Lean and Six Sigma.
• Excellent project management skills with the ability to lead cross-functional teams through complex projects.
• Strong written and verbal communication skills with a proven ability to work collaboratively across functions.
• Demonstrated strategic thinking and problem-solving abilities.
• Proficient in developing technical documentation, including:
  • Change Controls
  • Validation Plans and Protocols
  • Technical and Investigation Reports
  • SOPs and related documentation
• Self-motivated, proactive, and team-oriented professional.

Education & Experience

• Bachelor’s degree in Engineering (Mechanical, Industrial, Electrical, Chemical, or Biomedical preferred) or a related science field.
• Professional Engineer (PE) license is a plus.
• Lean/Six Sigma Green Belt or Black Belt certification preferred.
• Hands-on experience with validations, including:
  • Manufacturing equipment
  • Manufacturing processes
  • Stability and/or aging studies
• Minimum 7+ years of experience in a medical device and/or pharmaceutical manufacturing environment.

If you are interested in this role, then please click APPLY NOW. For other opportunities available at Akkodis, or any questions, please contact Punit Pathak at  or

Equal Opportunity Employer/Veterans/Disabled

Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, an EAP program, commuter benefits, and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.

Disclaimer:
These benefit offerings do not apply to client-recruited jobs and jobs that are direct hires to a client.

To read our Candidate Privacy Information Statement, which explains how we will use your information, please visit

The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:

• The California Fair Chance Act
• Los Angeles City Fair Chance Ordinance
• Los Angeles County Fair Chance Ordinance for Employers
• San Francisco Fair Chance Ordinance

• Mid-Senior level

• Contract

• Design, Engineering, and Manufacturing
• Industries:
  Medical Equipment Manufacturing and Pharmaceutical Manufacturing