Quality Validation Specialist The Validation Specialist is responsible for performing complex validation and qualification activities for critical equipment, utilities and processes used in cGMP. This position will need to travel frequently between the Manufacturing Facility and the Distribution Facility. The hours for this position are 7:00 a.m. until 3:30 p.m., overtime may be required, and the hours may need to be adjusted during peak periods, or to meet the needs of the company in certain situations. This is a salaried exempt role, due to the nature of the position.
Duties and Responsibilities:- Write and execute validation and re-validation protocols and reports, (IQ / OQ / PQ), for the validation of new and existing processes, equipment, systems, etc.
- Writes detailed validation reports and analyzes 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 the introduction of new products, as it relates to Cleaning Validation.
- Maintenance of the Cleaning Validation equipment and product matrix.
- Analyze statistical data to verify acceptable criteria.
- Maintains revalidation schedules ensuring the facility remains in a validated state.
- Writes and reviews SOP's related to qualification activities.
- Provide technical support/troubleshooting for process and equipment issues.
- Attend production and team meetings, as required.
- Troubleshoots and rectifies issues that are complex in nature.
- Maintain close contact with manufacturing and laboratory departments to assure effective communication on issues related to validation.
- Apply CGMP guidelines to all aspects of validation.
- Investigate/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 /systems.
- Critically review data to ensure completeness, accuracy and compliance.
- Apply CGMP and CGDP to all areas of work.
- Required Knowledge, Skills, and Abilities:
- 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.
- Bachelors Degree in Engineering or a related degree.
- Working Conditions and Physical Effort:
- Regularly able to lift and/or move up to 10 pounds, frequently lift and/or move up to 25 pounds, and occasionally lift and/or move 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.
- This role routinely uses 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.
Job Type: Full-time.
Pay: Compensatory based on experience.
