FSP-Associate Scientist - Sterile Ops Manufacturing Support

Thermo Fisher Scientific Inc.; Collegeville (PA); On-site; USD 55,000 - 75,000; Full time

Job summary

A leading company in scientific instrumentation is seeking a motivated Associate Scientist for Sterile Ops Manufacturing Support. This role involves cleaning and operating pharmaceutical equipment, ensuring compliance with safety standards, and contributing to continuous improvement initiatives. Candidates should hold a relevant Bachelor's degree and demonstrate strong analytical skills, attention to detail, and the ability to work in a team-oriented environment.

Qualifications

• Minimum 0-2 years of experience in a related field.
• Ability to obtain cleanroom gown qualification for Grade B environments.

Responsibilities

• Clean, disinfect, and operate pharmaceutical manufacturing equipment.
• Ensure compliance with regulatory standards and maintain accurate documentation.
• Contribute to continuous improvement initiatives in sterile manufacturing.

Skills

Analytical Skills

Troubleshooting

Attention to Detail

Education

Bachelor's degree in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or a related field

Job description

FSP-Associate Scientist - Sterile Ops Manufacturing Support

Pay Competitive

Location Collegeville/Pennsylvania

Employment type Full-Time

Job Description

Req#: R-01321175

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Is this ok for the JD?

Our client’s is seeking a highly motivated analytical scientist with an interest in performing sterile drug product manufacturing related activities as needed and directed at supporting MOH Sterile Drug Product Manufacturing clinical deliverables.

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 GSK’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 GSK’s Code of Conduct and contributing to a positive work environment.

Additional Responsibilities:

• Be prepared to work occasional overtime hours to meet the demands of sterile manufacturing operations.

Basic Qualifications:

• Bachelor's degree in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or a related field with a minimum 0-2 plus years of experiece.
• In some cases, an equivalency, consisting of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the role's requirements.

About the company

Thermo Fisher Scientific is an American provisioner of scientific instrumentation, reagents and consumables, and software and services to healthcare, life science, and other laboratories in academia, government, and industry.

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