Validation Engineer

Pay

Salary range: $65,000 to $80,000. Final pay determinations will depend on various factors, including experience level, education, knowledge, skills, and abilities.

Benefits

• 401(k) plan with company contributions
• Paid vacation, holiday and personal days
• Employee assistance program
• Health benefits: medical, prescription drug, dental and vision coverage
• Life insurance
• Disability coverage
• Wellness program

Responsibilities

This is an onsite, full-time salaried role; not eligible for visa sponsorship now or in the future.

• Provide technical support to operations for equipment/system/process initial validation and requalifications.
• Participate in process and equipment improvement teams to enhance compliance and performance of plant systems, considering regulatory requirements for change control.
• Become certified to enter Controlled Areas of the plant (class 100, 10,000 and 100,000).
• Write reports clearly, concisely and accurately; accurately record data and apply basic statistical analysis.
• Work weekends and off‑shift hours periodically.
• Schedule and execute equipment requalifications per SOPs; coordinate and communicate testing with affected functional groups and evaluate test results.
• Assemble and compose final reports and circulate for approval.
• Execute validation studies (utility, equipment, cleaning, process, computer, and new products) including protocol preparation, scheduling, execution, and final report preparation; present results to Regulatory Agency when necessary.
• Program and operate department analytical instruments (e.g., temperature/humidity dataloggers) to perform controlled temperature/humidity chamber qualifications (lyophilizers, warehouses, sterilizers, incubators, etc.).
• Develop/improve validation programs as needed to remain current with cGMPs and industry standards.
• Schedule and execute HEPA Filter and Critical Area (Class 100) testing per SOP; program and operate test equipment such as smoke generators, photometers, velocity meters, etc., and accurately record and evaluate results.
• Represent Technical Services in teams assembled to specify, install, validate, troubleshoot and maintain systems, equipment and processes.
• Ensure compliance with company documents, programs and activities related to Health, Safety, Environment, Energy, and Quality Management Systems per role responsibilities.

Requirements

• Bachelor’s degree in a Science or Engineering field of study.
• Minimum of one year relevant work experience in a cGMP regulated industry.
• Experience generating reports, deviations or other technical documents.
• Experience with Installation, Operational and Performance Qualification protocol generation and execution strongly preferred.
• Analytical datalogger programming, operating, troubleshooting, data‑collecting preferred.
• PC literate with standard office applications (Word, Excel, PowerPoint, Project, Access).
• Knowledge of cGMP room classifications, HEPA filter testing and Airflow Pattern testing tools and techniques.
• Knowledge of cGMP Cleaning Validation requirements and techniques.
• Knowledge of cGMP Process and Product Validation requirements and techniques.
• Ability to effectively speak, read, write, and understand English to perform essential functions, including independently understanding policies, procedures, training materials, and workplace communications.