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 a real-world impact, and you2019ll be supported in achieving your career goals.

Location/Division Specific Information

Pharmaceutical Services Group

How will you make an impact?

Provides validation expertise and supervision of multiple complex activities for process, equipment and/or computer validation associated with products produced by the Company. Supervises and/or leads lower level staff as assigned. Designs, implements, and documents validation for manufacturing equipment, utility systems, facilities, and manufacturing processes. Coordinates the implementation of interdepartmental process validation programs. Performs validation functions to ensure accurate and timely completion with frequent decision making, coordination and communications required. Creates, reviews, approves, tracks and presents documents and procedures required for compliance with pharmaceutical regulations. Identifies areas of non-compliance, review recommendations of others and implement solutions to resolve major quality and productivity issues.

Implements systems to ensure compliance with new and changed regulations. Performs activities across key quality functions to support the business units. Prepares and conducts quality systems training across the company.

What you will do

1\. Serves as a principle technical expert in regards to validation activities associated with equipment, computers, and processes. Serves as the validation expert for the design, implementation, and documentation of validation for manufacturing equipment, utility systems, facilities, manufacturing processes and computer/information/automation validation.

2\. Leads multiple complex validation activities associated with computers, equipment, and processes.

3\. Prepares, reviews and approves production, validation, audit reports, risk assessments, and/or master batch record documents, procedures, and rationales.

4\. Understands the process of documentation in the NDA drug approval process under the FDA Pre-Approval Inspection programs.

5\. Coordinates validation associated audit activities; establish rationales and technical defense positions.

6\. Negotiates with clients the validation requirements for projects. Resolves significant validation, product and regulatory issues. Plans and establishes technical communications, document flow, testing requirements, and resources necessary to complete the validation of a system.

7\. Supports systems and new product introduction by serving as a technical resource, providing technical

expertise, problem solving, and strategies for problem prevention.

8\. Participates as the validation representative in project team activities and process design to insure Current Good Manufacturing Practices (cGMP) compliance and interdepartmental consistency within the validation

program.

9\. Assures compliance to all applicable regulations by proactively interpreting regulatory and compliance requirements as related to validation.

10\. Maintains current knowledge and serve as a technical resource for emerging trends and technologies.

11\. Coordinates and provides training and/or opportunities for career development of others. Identifies training needs and assists develop training programs.

12\. Performs other duties as assigned.

How you will get here

Education:

Bachelor2019s degree in a scientific or production related discipline is required. Minimum High School Diploma/GED required

Experience:

Six years experience in the pharmaceutical industry that includes two years validation experience preferred.

At Thermo Fisher Scientific, each one of our 75,000 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.