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 pharmaceutical manufacturing is looking for a highly motivated Analytical Scientist to support sterile drug product manufacturing activities. The successful candidate will be involved in cleaning, operating, and ensuring compliance with GMP standards for manufacturing equipment while fostering team collaboration and continuous improvement.

Qualifications

• Requires a Bachelor's degree in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or a related field.
• 0-2 years of experience in sterile drug manufacturing is preferred.
• Strong analytical skills and understanding of GMP standards is essential.

Responsibilities

• Clean and operate pharmaceutical manufacturing equipment.
• Maintain compliance with cleaning and operational standards.
• Provide training to new team members on cleaning protocols.

Skills

Analytical skills

Troubleshooting

Team collaboration

GMP Compliance

Quality Assurance

Education

Bachelor's degree in Chemistry

Bachelor's degree in Chemical Engineering

Bachelor's degree in Pharmaceutical Sciences

Job description

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

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 areasin accordance with established protocols and cGMP standards.
• Operate and troubleshoot pharmaceutical manufacturing equipmentto ensure optimal performance, addressing routine technical issues promptly and escalating complex problems as needed.
• Performequipment and line clearancefor 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 maintaincleanroom gown qualification for Grade B environments, strictly adhering to gowning protocols and good hygiene practices.
• Ensure all cleaning, disinfection, and operational tasks align withGSK’s Behavior Expectationsand 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, ensuringzero instances of data falsificationor procedural deviations.

Continuous Improvement and Training:

• Actively contribute tocontinuous 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 ateam playerin a collaborative, team-based culture, fostering productive workplace relationships and supporting colleagues as needed.
• Lead by example, upholdingGSK’s Code of Conductand 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.

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.