FSP-Associate Scientist - Sterile Ops Manufacturing Support
ThermoFisher Scientific
**Work Schedule**
Standard (Mon-Fri)
**Environmental Conditions**
Office
**Job Description**
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 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.
+ 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.
**Additional Responsibilities:**
+ Be prepared to work occasional overtime hours to meet the demands of sterile manufacturing operations.
_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._
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.
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