Sr. Validation Specialist
As our Senior Validation Specialist, you will play a key role in ensuring compliance in all areas requiring validation. You will be responsible for ensuring the validation team’s strategy is successfully implemented through effective coordination, planning, and execution of validation programs.
- Oversee validation to support systems and programs under our high-quality standards and cGMP regulations.
- Prepare and present validation plans, reports, equivalencies, and stability protocols.
- Manage project schedules, budget, support staff, and execution.
- Communicate internally to the validation team and externally to contractors to ensure the implementation and execution of validation activities.
- Perform complex assessments for automated processing systems against current industry compliance requirements.
- Build cross-functional relationships to drive organizational processes and growth.
- Oversee new equipment performance specification development to ensure compliance.
- Champion opportunities to optimize quality, design, processes, and performance.
- Review and approve of CQV protocols.
- Motivate, direct, and manage employees and contractors effectively and efficiently.
- Work with cross-functional teams to develop and implement operating and preventative maintenance procedures for equipment across the organization.
- Perform additional responsibilities as requested or assigned.
- B.S. or M.S. in Engineering or related field
- Five years of validation leadership experience within a cGMP environment
- Highly organized and detailed-oriented
- Able to work in a fast-track pace environment
- Excellent written and verbal communication skills
- Experience with utilities, sterilization, and depyrogenation equipment validation
- Preferred but not required: experience with isolators, inspection equipment, and cleaning validation
TriPharm Services, Inc. is an equal opportunity employer committed to providing employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age or disability, or any other class protected by Federal, State or local laws. TriPharm complies with all employment eligibility verification requirements of the Immigration and Nationality Act, and all must have the authorization to work in the U.S.