When you join us at Thermo Fisher Scientific, you’ll be part of a smart, driven team that shares your passion for exploration and discovery. With revenues of $22 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.

What will you do?

• Ensure all GMP equipment/instruments and devices are in a qualified/certified state.
• Responsible for performing validation of equipment, utility systems, facilities, processes and/or automation systems by following approved standard operating procedures (SOPs), current Good Manufacturing Practices (GMPs) and all other regulatory requirements.
• As required, prepares reports/summaries of validation testing/metrics for tracking and reporting purposes.
• Is able to work independently and able to apply validation principles to work assignments, reviews and approves documents and resolves problems.
• Contributes directly to the completion of projects through the management of assigned contract personnel, development and execution of validation change control documents, and development and review of protocols, reports and data tables generated by peers and contract personnel.
• Certify FBS environmental monitoring/recording devices.
• Participate, facilitate and/or support validation training and project management activities as required.
• Maintains all documentation pertaining to validation
• Participates on cross-functional project teams like Operations, Facilities, and Quality Assurance groups.
• Coordinates assigned projects and represents department on project teams.
• Must be able to provide day-to-day project completion guidance.
• Serves as an information resource to contractors and vendors.
• Resolves validation issues of moderate scope with limited direct supervision.
• Participate in process improvement activities.
• Assure compliance to cGMP parts 210 and 211 and company quality systems.
• Follow standard operating procedures (SOPs), facility safety guidelines, and Food & Drug Administration (FDA) requirements which may include compliance with cGMP CFR parts 210 and 211 where applicable.
• May be required to travel to other facilities to meet business needs.
• Other duties may be assigned to meet business needs.

How will you get here?

The qualifications listed below are representative of knowledge, skill and/or ability. To perform this job successfully, an individual must be able to complete each essential duty.

Education

• Requires a High School Diploma; Associate degree in Engineering/life science field preferred.

Experience

• Requires ability to communicate effectively verbally and in written form.
• Ability to prepare reports using Excel; knowledge of Windows, Word and Access preferred.
• Knowledge of Universal Precautions, general laboratory and quality assurance/control preferred.
• Valid driver’s license and good driving record if required to travel to other locations.
• Prefer hands-on industry experience in cGMP/Biotech/Biopharmaceutical/FDA regulated industries.
• Prefer experience with Current Good Manufacturing Practices (cGMP).
• Prefer ability to perform NIST traceable temperature and humidity measurements with a variety of temp/humidity measurement devices.
• Prefer Validation experience with Cleaning Validation; Equipment Validation; Critical Utility Systems Temperature Mapping/ Kaye Validation platform/ Controlled Temperature Units/ Freezers/Data Loggers.
• Prefer Qualification experience with IQ/OQ/PQ protocol development/writing/execution; GAMP; Facilities; Utilities/HVAC; Process Equipment; Final Reports.
• Prefer basic knowledge of refrigerator and freezer operation and temperature distribution patterns in storage spaces.

Work Schedule

• 8AM to 5PM core hours, additional hours as required.
• Requires ability to travel on a local level. May be required to occasionally travel nationally.

Work Conditions/Physical Requirements

• Must be able to work in a cold environment with exposure to dry ice, liquid nitrogen cryogenics, hazardous and infectious agents, marked changes in temperature.
• May push/pull 600 lb liquid nitrogen dewars, and work from a platform ladder.
• Must use personal protective equipment and adhere to safety protocols.
• Must be able to lift and carry up to 50 lbs, and push up to 70 lbs.
• Must be able to process and handle materials frozen on dry ice (-78°C) or liquid nitrogen (-195°C).
• Must be able to work in walk-in freezers or refrigerators periodically for up to 5 hour per day.
• Must be able to use a computer up to 6 hours per day.
• Must be able to travel to client sites as needed and assigned.

Disclaimer:

This job description is intended to present the general content and requirements for the performance of this job. The description is not to be construed as an exhaustive statement of duties, responsibilities, or requirements. Managers and supervisors may assign other duties as needed.

Nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.

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 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.