Job Description

When you2019re part of the team at Thermo Fisher Scientific, you2019ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you2019ll be supported in achieving your career goals.

Location/Division Specific Information

St. Louis, MO

Pharma Services Group

How will you make an impact?

This is a working supervisor position. In addition to generating validation lifecycle documentation, the Validation Supervisor will have responsibility over the day to day validation activities at the St. Louis facility. The primary oversight responsibilities include validation maintenance, equipment, utilities, and sterilization processes, but may also include computer systems, automation, facilities, and cleaning (requalifications). The Supervisor ensures the validation program is in compliance with regulatory agency and corporate expectations by writing and revising policies and SOPs as necessary. They will review and approve plans/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. This individual provides leadership to assigned staff by performing the following: developing and empowering staff; managing resources; 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?

* Oversee, manage, and ensure the successful day-to-day operations of Validation department.
* Develop and enforce strategy to ensure that validation and re-validation activities are robust and efficient, helping to develop and use tools to drive continuous improvement with quality and validation methodologies.
* You will also line manage a team accountable for all aspects of validation and re-validation activities to maintain performance as required by schedule and/or project timelines.
* You will be responsible for control of all documentation of validation life-cycle management: preparation, coordinating execution, reviewing, and approving in-depth validation protocols and reports.
* This is a working supervisor position. You will guide direct reports to coordinate and execute validation efforts for key site projects to implement new equipment, technology, processes or materials as required by the needs of the business. You will also be responsible for coordination and execution of individual validation assignments as required.
* As part of the role you will represent the company at audits and inspections (internal, external including FDA, EU, etc.), respond to questions, coordinate responses and corrective actions as appropriate.
* In addition you will provide subject matter expertise associated with validation requirements for change management.
* You will be required to lead reviews of existing validation processes and systems and generate actions to drive improvement and ensure appropriate standards are met. You will also oversee and direct the department to build organizational capacity and ensure area goals are met.

How will you get here?

Education

* High school diploma / GED required.
* Bachelor2019s Degree in Engineering, Science or other related technical discipline is preferred.

Experience

* 5+ years of experience within a GMP Environment (preferably pharmaceutical)
* 3-5 years of experience within Validation
* Previous supervisory experience is preferred

Knowledge, Skills, Abilities

* Working knowledge of controlled documentation and data systems.
* In depth knowledge of cGMP regulations.
* 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 positively influence site departments and lead significant change.
* Strong communication skills, both written and verbal, to all levels of management.
* Ability to work on multiple projects simultaneously.
* Strong proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint).
* Effective presentation skills.

At Thermo Fisher Scientific, each one of our 70,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission2014enabling 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.