Senior Validation Professional- Medical Device
4 weeks ago
About the Position This is an exciting opportunity to manage the validation lifecycle and Advanced Product Quality Planning (APQP) processes for this busy medical device manufacturing plant.
Key Responsibilities Lead and Manage the Validation Team: Oversee daily operations, allocate work, and ensure high performance and quality output.
Drive Validation Projects: Serve as the lead on all validation projects, ensuring alignment with protocols and production requirements.
Ensure Compliance: Develop strategies to meet regulatory requirements, maintain validation policies and procedures, and manage the Validation Master Plan.
Lifecycle Management: Oversee product and process transfers, manage PFMEA and control plans, and support post-validation activities.
Technical Execution: Lead IQ, OQ, PQ, and process development activities, including DOE and MSA, to ensure process effectiveness.
Cross-Functional Collaboration: Work closely with Operations, Planning, and Engineering teams to validate manufacturing processes.
Regulatory Audits: Participate in regulatory audits and ensure all validation activities meet industry standards.
Experience/Requirements Minimum 5 years of high-volume engineering experience in the medical device industry 3 + years of experience in validation processes BA/BS Engineering or related technical qualification Proficient in statistical techniques, including Minitab, Six Sigma (preferably Green Belt), and Sampling Plans/Sizes.
Strong experience in process development, DOE, and risk management (FMEA).
Excellent documentation skills and a strong understanding of process validation.
Proven ability to lead a team, manage projects, and communicate effectively across departments Strong problem-solving skills and the ability to work independently or as part of a team.
Remuneration Package A competitive package is on offer which will include salary, benefits and bonus.
Contact For more information on this position or other life sciences roles, please contact Charlie Biggeron oremailor simply click the apply button.
To view all live jobs with Brightwater and market insights, please visit our website: Skills: medical device validation equipment process development Leadership
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