FSP-Associate Scientist - Sterile Ops Manufacturing Support
FSP-Associate Scientist - Sterile Ops Manufacturing Support
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Salary Not Disclosed
1 Vacancy
Job Description
Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob Description
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 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 withGSKs 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 upholdingGSKs 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:
- Bachelors 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 roles requirements.
Required Experience:
IC
Employment Type
Full-Time
