Thermo Fisher Scientific Manager, Validation in Saint Louis, Missouri
The Validation Manager will have responsibility over the validation maintenance program at the St. Louis facility. This includes, but is not limited to, equipment, facilities, utilities and computer systems for biological manufacturing processes, cleaning, and sterilization processes. The Manager ensures the validation program is following regulatory agency expectations by writing and revising SOPs as necessary. They will review and approve protocols, final summary reports and periodic reviews as the validation signatory. They will also be responsible for validation deliverables for projects and participate as an interactive member on project teams.
Location/Division Specific Information
St. Louis / Patheon, Bio services Division
How will you make an impact?
Provides leadership to assigned staff by performing the following: developing and empowering staff; cultivating relationships; putting staff in a position to succeed, meeting their personal career goals while also achieving organizational goals; building effective teams that apply their diverse skills and perspectives to achieve common goals; driving engagement and creating a climate where staff are motivated to do their best.
What will you do?
Oversees, manages, and ensures the successful day-to-day operations of Validation department for the company.
Develop and enforce strategy to ensure that validation and re-validation activities are robust and efficient, helping to develop and use tools such as statistical analysis and process robustness techniques to drive ongoing quality and process improvements to the validation business processes.
You will also line manage a team accountable for all aspects of validation and re-validation activities (equipment, process, facility, cleaning, computer systems, etc.) to maintain performance as required by schedule and/or project timelines.
You will be responsible for control of all documentation of validation lifecycle management. Preparing, coordinating execution, reviewing, and approving in-depth process validation protocols and reports (equipment, process, facility, cleaning, computer systems, etc.).
You will co-ordinate and execute validation aspects for key site projects to implement new equipment, technology, processes, or materials as required by the needs of the business aligned to the site objectives.
As part of the role you will represent the company at regulatory inspections (internal, external including FDA & MHRA), respond to questions, co-ordinate responses and corrective actions as appropriate.
In addition, you will provide subject matter expertise associated with validation requirements for change controls.
You will be required to lead reviews of existing processes and systems and generates actions to drive improvement and ensure appropriate standards are met. As well as oversee and direct the department to build organizational capacity and ensure area goals are met.
How will you get here?
Bachelor's Degree in Engineering, Science or other related technical disciple
8+ years within a GMP Environment
5 + years of experience within Validation
2 + years of supervisory experience is preferred.
Proficient with computers (MS Office). Working knowledge of controlled documentation and data systems.
In depth knowledge of cGMP regulations.
Knowledge, Skills, Abilities
Work attitude that exhibits drive, creativity, collaboration, assertiveness, good judgment, decision-making and ambition.
Excellent interpersonal skills: ability to build and maintain relationships with internal and external customers; highly functioning team leader and team member in a multi-skilled, dynamic business environment.
Leadership Skills: Proven ability to influence others and lead significant change.
Strong communication skills both written and verbal
Ability to work on multiple projects simultaneously.
Strong proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint).
Effective written, interpersonal, and presentation skills.
At Thermo Fisher Scientific, each one of our 65,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission-enabling our customers to make the world healthier, cleaner and safer.
Apply today! http://jobs.thermofisher.com
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.