SRG, the leader in the Life Sciences human capital industry, is looking for a Process Validation consultant to join our client's medical device manufacturing team in Devens, Mass. This person will be responsible for leading and executing activities across manufacturing processes. This role will focus on developing and implementing robust validation protocols, conducting PFMEAs, and ensuring test methods are accurate, repeatable, and compliant with industry standards.

*We cannot accept visa status candidates at at this time

*M-F onsite

Must Haves:

• 10 years of experience in/leading up to Process Validation
• Career in medical device manufacturing *be sure to indicate on resume
• Orthopedic experience will be prioritized *be sure to indicate on resume
• FMEAs
• IQ/OQ/PQ experience with medical devices

Roles and Responsibilities:

• Develop and execute process validation plans, protocols, and reports for new and existing manufacturing processes.
• Lead and facilitate Process Failure Modes and Effects Analysis (PFMEA) sessions to identify and mitigate risks.
• Design and validate test methods to ensure product quality and regulatory compliance.
• Collaborate with cross-functional teams including Quality, Engineering, and Manufacturing to support continuous improvement initiatives.
• Analyze data from validation activities and provide recommendations for process optimization.
• Maintain documentation in accordance with internal procedures and regulatory requirements.
• Write and maintain detailed work instructions, standard operating procedures (SOPs), and process documentation to ensure repeatable and high-quality production.

** Only candidates selected to be moved forward in the recruitment process will be contacted by SRG's Recruitment Team to schedule a conversation.

Impellam Group and its brands are equal-opportunity employers committed to diversity and inclusion. All qualified applicants will receive consideration without regard to race, color, religion, gender, sexual orientation, pregnancy or maternity, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application, interview process, pre-employment activity, and the performance of crucial job functions.

If you require additional disability considerations, modifications, or adjustments please let us know by contacting HR-InfoImpellamNA@impellam.com or fill out this form to request accommodations.