Sr. Validation Specialist – TOLMAR Inc. – Fort Collins, CO
Responsible for the development and execution of validation activities including, design, installation, and operational qualification of equipment/utilities/facilities, process validation for all manufacturing processes, lab equipment qualification, and cleaning validation. Writes, executes, or reviews all of the above listed protocols and reports.
Essential Duties & Responsibilities
- Develops validation strategies for complex validation projects.
- Develops and implements creative solutions to complex problems.
- Work with various departments to assign responsibility for protocol generation, execution, and review.
- Responsible for the change control system for all validated processes and equipment.
- Write and maintain site and special projects Master Validation Plans.
- Plans and coordinates the validation activities for projects.
- Work with Process Development, Engineering, and Maintenance in establishing equipment purchase requirements from the validation perspective.
- Responsible for the appropriate qualification of equipment, including its controls systems.
- Validate environmental controlled environments (warehouse, cold/hot chambers, etc), including product cold-chain transportation systems.
- Validate aseptic equipment (liquid and powder filling equipment, isolator, lyophilizer, autoclave, de-pyrogenation oven, Steam-In-Place, etc.).
- Validate cleaning processes (manual or automated).
- Validate manufacturing processes (liquid, semi-solid, solid bulks, filling, labeling, and packaging).
- Interface regularly with Engineering, Facilities, Regulatory, and Manufacturing personnel.
- Provide guidance and leadership over engineers who will write and execute protocols, but reporting into other managers.
- Perform other related duties as assigned.
Education & Experience
- Bachelor’s degree in Engineering or related field.
- Seven or more year’s experience in the pharmaceutical industry, with a minimum of 3 years in validation activities.
- Experience in Statistical Analysis a plus.
Knowledge, Skills & Abilities
- Proficient knowledge with MS Office.
- Full understanding and knowledge of domestic and international GMP regulations and industry standard for validation activities.
- Knowledge and experience in writing protocols and procedures.
- Skilled at utilizing typical validation tools such as Kaye Validator,
- Excellent oral and written communication skills demonstrated through interactions internally and externally.
- Effective organization and project management skills.
- Efficient in report writing and technical writing skills.
- Effective troubleshooting and problem solving skills.
- Ability to execute the validation efforts for the company.
- Ability to manage multiple projects simultaneously.
- Ability to work both independently and in conjunction with a team.
- A valid driver’s license and acceptable Motor Vehicle record required.