Perform cGMP upstream biomanufacturing operations (vial thaw, inoculation, cell culture, recovery), support equipment setup/calibration, troubleshoot processes, complete accurate batch documentation, maintain inventory, and support quality, safety, and regulatory audit readiness during rotational shift work.
Company Description
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.
Job DescriptionPurpose:
- Performs functions associated with cGMP manufacturing operations within the biologics production facility, including working with engineers in set-up and calibration tasks, as well as performing rework and quality testing related to the production of parts, components, and final materials.
- Completes batch documentation accurately and thoroughly, while adhering to the required quality and safety standards, and in a productive, cost-effective manner.
- Supports operations & troubleshooting efforts during course of shift work to ensure adherence to schedule and production plan.
Major Responsibilities:
Key Responsibilities Summary:
- Performs cGMP upstream manufacturing operations (e.g., vial thaw, inoculation, cell culture, and recovery).
- Works with engineers on setup and calibration tasks, as well as performing rework and quality testing related to the production of parts, components, and final materials.
- Ensures batch documentation is completed accurately while adhering to required quality and safety standards.
- Supports operations and troubleshooting efforts during the course of shift work to ensure adherence to the schedule and production plan.
Operations and Technical
- Adhere to cGMP and safety requirements
- Executes manufacturing operations to perform operations including but not limited to equipment cleaning and set up as well as stream specific operations like:
- Upstream: Vial Thaw, Inoculation, Cell Culture and Recovery
- Downstream: Chromatography, Filtration, Ultrafiltration, Final Filling
- Central Service: Buffer/ Media Preparation, Autoclave, Glasswash and cleaning processes, Sampling of raw materials.
- Carry out daily tasks as assigned by Lead Biotechnologist or Manufacturing Supervisor
- Accurately completing documentation on time, accurately and legibly.
- Maintains inventory levels to minimize distress
- Ensures training is complete and current.
- Responsible for overall plant upkeep during the shift.
- Reports any anomalous processing events to Lead Biotechnologist or Manufacturing Supervisor timely.
Safety
- Adhere to and support all EHS & E standards, procedures, and policies.
Quality
- Accurately completes documentation on time, accurately and legibly
- Reviews documentation for the completeness and accuracy.
- Ensures that all batch related document errors are resolved in a timely manner
- Support in preparation for regulatory audits and inspections
Schedule
- Adheres to production schedule
- Escalates to Lead Biotechnologist or Manufacturing Supervisor in events of unplanned downtimes.
Education
- Degree or higher in Sciences, Engineering, or equivalent, with 3–5 years of relevant work experience in the biotechnology or pharmaceutical industry, is preferred.
Essential Skills, Experience, and Competencies (includes Licenses, Credentials)
- Good working knowledge of cGMP and regulatory requirements related to Manufacturing is preferred
- Experience with SAP, LIMS, MES systems preferred
- Possess problem-solving and troubleshooting skills.
- Highly motivated and independent.
- Works and communicates with others in a professional and effective manner, within a team-oriented environment.
- Rotational shift work is required
- Higher job level commensurate with experience
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
https://www.abbvie.com/join-us/reasonable-accommodations.html
AbbVie Singapore, Singapore, SGP Office
9 North Buona Vista Drive, Singapore, Singapore, Singapore, 138588
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