FSP-Associate Scientist - Sterile Ops Manufacturing Support

Work Schedule

Environmental Conditions

Job Description

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Our clients 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 GSKs 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 GSKs 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.