Labs FSP - Sterile Manufacturing Operator

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Thermo Fisher's clinical research business is a leading global contract research organization and world leader in serving science. We are passionate, deliberate, and driven by our mission – to enable our clients to make the world healthier, safer, and cleaner.

Within our Analytical Services team, we have a functional service provider solution, which is an outstanding partnership that allows our customers to use the experience of our staff, while allowing you, the employee, to gain direct experience working onsite at a pharmaceutical/ biopharmaceutical company, all while maintaining full-time benefits.

Key Responsibilities

Equipment Cleaning, Disinfection, Operation, and Troubleshooting:

• Clean, disinfect, and sanitize pharmaceutical manufacturing equipment and associated GMP areas in accordance with established protocols and cGMP standards.

• Operate and troubleshoot pharmaceutical manufacturing equipment to ensure optimal performance, addressing routine technical issues promptly and escalating complex problems as needed.

• Perform equipment and line clearance for applicable equipment and rooms, ensuring readiness for sterile manufacturing operations.

• Support equipment maintenance activities by conducting routine inspections, assisting with basic repairs, and coordinating with maintenance teams.

• Maintain accurate documentation of cleaning, disinfection, equipment operation, and troubleshooting activities to ensure compliance with regulatory requirements.

Quality and Compliance:

• Obtain and maintain cleanroom gown qualification for Grade B environments, strictly adhering to gowning protocols and good hygiene practices.

• Ensure all cleaning, disinfection, and operational tasks align with the client’s Behavior Expectations and regulatory standards.

• Identify and report any risks related to equipment performance, cleaning, or disinfection processes for management consideration.

• Collaborate with area management to resolve quality or safety risks and assist in GMP and safety self-inspection activities.

• Uphold data integrity, ensuring zero instances of data falsification or procedural deviations.

Continuous Improvement and Training:

• Actively contribute to continuous improvement initiatives, such as GEMBAs and RCAs, to enhance cleaning processes, equipment operation, and overall sterile manufacturing efficiency.

• Identify opportunities to optimize cleaning protocols, disinfection techniques, and equipment usage while maintaining compliance with industry regulations and GSK policies.

• Provide technical training to new or less experienced team members, focusing on equipment cleaning, troubleshooting, and operational best practices.

• Proactively communicate the status of compliance systems and escalate issues in a timely manner.

Complementary Administrative and Support Tasks:

• Assist in restocking sterile manufacturing areas and maintaining consumables inventory to support operational activities.

• Perform administrative tasks, such as revising procedures, filing records, and archiving documents, as required.

• Help maintain general housekeeping and upkeep of GMP areas to support a clean and organized work environment.

• Collaborate with external personnel and contractors to ensure seamless operations during equipment inspections or maintenance activities.

Team Collaboration and Workplace Culture:

• Commit to being a team player in a collaborative, team-based culture, fostering productive workplace relationships and supporting colleagues as needed.

• Lead by example, upholding the client’s Code of Conduct and contributing to a positive work environment.

Education and Experience:

• High school diploma or GED

• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0-1+ years).

In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!