The Process Validation Engineer (PVE) tests systems and processes as the owner of the process validation program to ensure the highest quality products are manufactured. S/he investigates process deviations, investigates assignable root causes for equipment, system or process failures and establishes appropriate corrective and preventive actions. The PVE ensures processes are performed and documented accurately, timely and in compliance with SOPs, cGMPs and FDA requirements in an ISO 13485 environment.

Responsibilities:

• Develops and implements strategic and tactical plans to create a process validation program.
• Executes equipment qualification protocols and accurately documents results of the defined testing; compares and reports those results to predefined/approved acceptance criteria using statistical knowledge.
• Organizes and presents qualification data, results, documentation, and reports within the appropriate equipment/system validation files and system manuals.
• Writes, reviews and approves technical documents and reports such as protocols, SOPs, filing documentation and other cGMP documents related to process validation.
• Designs and develops process validation strategies to evaluate the reliability of the process validation program.
• Evaluates process changes and effect on validated state to ensure equipment and systems remain in a qualified state.
• Functions as the Subject Matter Expert and technical resource on data collection and statistical analysis for internal partners including Process Engineers and Quality Engineers.
• Creates and maintains validation programs schedules.
• Functions as technical resource to NPI Product Development Teams to provide process validation requirements for new product development.
• Drives process risk management activities. Ensures identified activities and mitigations are executed as agreed and approved.
• Becomes familiar with the applicable process technology to facilitate participation in technical discussions and risk-based decision making; coordinates issue resolution use a risk-based approach.
• Provides management with status updates on assigned responsibilities and goals and escalates issues in a timely manner.

Qualifications:

• Bachelor’s degree in engineering discipline plus 5-8 years of hands on process validation experience in medical device or an equivalent combination of education and experience
• Ability to understand the development and execution of qualification protocols (IQ/OQ/PQ concepts) and other validation lifecycle documents.
• Strong understanding of cGMPs, FDA, OSHA, and other local, state and federal regulatory requirements associated with medical device/orthopedic implant manufacturing facilities and associated equipment
• Excellent technical writing and organizational skills
• Thorough understanding of basic statistical concepts
• Highly effective communicator. Able to facilitate difficult conversations and negotiate solutions among different department representatives.
• Good interpersonal skills and the ability to work well in a team environment