Validation Engineer, Senior
About The Position
The Validation Engineer is the architect and primary owner of the site-wide equipment and process validation program. Reporting to the Director of Operations Quality, this individual operates with minimal direction to establish and sustain a robust validation function. They are responsible for developing the validation master plan (VMP), writing and executing validation protocols for equipment and processes, evaluating changes for impact to validation status, and training other engineering associates on validation concepts to strengthen integration of the validation program into the manufacturing organization.
Requirements
- Four-year degree in an engineering, a technical, or a scientific discipline
- At least 5 years of experience in a cGMP or an ISO-regulated environment, including validation experience
- Experience navigating a business environment that is undergoing rapid change (e.g., startup, acquisition)
- Proven ability to lead through clear communication, critical thinking, and confident decision making
- Experience effectively coaching less experienced team members, including upskilling through training and mentoring and promoting a culture of accountability by example
- Demonstrated capability to manage relationships, including by managing up, developing customer relationships, and driving team engagement
- Proficiency in quality improvement tools and techniques
- Proficiency with standard business tools (e.g., Outlook, Word, PowerPoint, Excel, Visio)
Nice To Haves
- Experience with ISO 13485 and/or 21 CFR 820
- Experience managing direct reports
Responsibilities
- Develop, implement, and own the VMP and associated standard operating procedures (SOPs).
- Drive the validation program to raise internal standards and exceed customer expectations, particularly for PCBA and cable component manufacturing.
- Apply prior experience, critical thinking, and sound judgment to prioritize new validation-related projects and identify system-wide improvements.
- Perform rigorous analysis of processes and trends to keep executive management informed of key metrics and to recommend improvements.
- Lead validation protocol development, training, execution, closure, and reporting (IQ/OQ/PQ).
- Maintain a validation approach that effectively verifies manufacturing processes are robust and repeatable, with appropriate controls in place.
- Ensure that equipment is evaluated for applicability of qualification and that functionality is challenged appropriately when required.
- Serve as a subject matter expert (SME) for change management, identifying triggers to validate for new and existing equipment and processes and conducting detailed risk assessments.
- Document all plans and results as defensible supporting evidence for customers and regulatory interested parties.
- Promote a culture of accountability by example and through coaching, mentoring, and upskilling.
- Effectively manage up and cross-functionally to drive team engagement.
- Develop strong and collaborative customer relationships.
- Act as the site SME by training staff on validation principles and new SOPs.
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Senior
