Quality Validations Specialist

Quality Validation Specialist.

The Validation Specialist is responsible for performing complex validation and qualification activities for critical equipment, utilities and processes used in cGMP. The position requires frequent travel between the Manufacturing Facility and the Distribution Facility. Hours are 7:00 a.m. to 3:30 p.m.; overtime may be required and hours may be adjusted during peak periods. This is a salaried exempt role.

• Write and execute validation and re‑validation protocols and reports (IQ/OQ/PQ) for validation of new and existing processes, equipment, systems, etc.
• Write detailed validation reports and analyze complex quality data.
• Plan and execute cleaning validation activities.
• Perform and/or coordinate cleaning studies, spray coverage testing, cleaning verification swabbing, and rinse sampling.
• Provide technical input for control strategies for introduction of new products as it relates to Cleaning Validation.
• Maintain the Cleaning Validation equipment and product matrix.
• Analyze statistical data to verify acceptable criteria.
• Maintain revalidation schedules to ensure the facility remains in a validated state.
• Write and review SOPs related to qualification activities.
• Provide technical support/troubleshooting for process and equipment issues.
• Attend production and team meetings, as required.
• Troubleshoot and rectify complex issues.
• Maintain close contact with manufacturing and laboratory departments to assure effective communication on validity issues.
• Apply CGMP guidelines to all aspects of validation.
• Investigate and resolve deviations associated with validation studies.
• Author technical documents such as protocols, reports, deviations, gap analyses, risk assessments, etc.
• Provide technical and/or investigational support in troubleshooting and resolving manufacturing equipment issues.
  
  Perform periodic review of equipment and systems.
• Critically review data to ensure completeness, accuracy and compliance.
• Apply CGMP and CGDP to all areas of work.

• Strong organization and communication skills; high level of personal/departmental accountability and responsibility.
• Ability to manage multiple priorities and tasks in a dynamic environment.
• Ability to exercise judgment to determine appropriate corrective actions.
• Ability to exercise judgment for defined practices and policies in selecting methods and techniques for obtaining solutions.
• Minimum of four (4) years of relevant GMP metrology, validation, or process engineering experience.
• Previous FDA experience is a plus.
• Detail oriented with strong written and verbal communication skills.
• Ability to work independently, within prescribed guidelines, or as a team member.
• Experience with Google Suite and Microsoft Office applications.
• Bachelor’s Degree in Engineering or a related degree.

• Regularly able to lift and/or move up to 10 pounds, frequently up to 25 pounds, and occasionally up to 50 pounds.
• Standing, sitting, or walking for more than 8 hours a day.
• Able to work in high heat and humidity or cold and dry conditions indoors/outdoors.
• Full range of motion to lift, carry, walk, climb around equipment and facilities.
• Work in elevated positions on ladders, lifts, and platforms.
• Work involves moderate exposure to unusual elements such as extreme temperatures, dirt, dust, fumes, smoke, unpleasant odors, and/or loud noises.
• Routine use of standard office equipment such as computers, phones, photocopiers, filing cabinets, and fax machines.
• Wearing PPE as necessary for the job.

Reports to Director of Quality Assurance.

Full‑time.

Compensation based on experience.