Biotechnologist, Manufacturing Operations (Biopharma|Shift |Contract)

Manpower Staffing Services (Singapore) Pte Ltd; Singapore; In loco; SGD 37.000 - 61.000; Tempo pieno

Descrizione del lavoro

Manpower Staffing Services (Singapore) Pte Ltd seeks a Biotechnologist to support cGMP manufacturing operations in a biologics production facility. You will work with engineers on setup and calibration, perform rework and quality testing, and ensure precise documentation.

The role involves upstream and downstream processes and requires good problem-solving skills. Responsibilities include adhering to safety standards, maintaining schedules, and supporting audits.

Competenze

• 1-4 years of relevant work experience in Biotechnology / Pharmaceutical industry
• Degree in Sciences, Engineering, or equivalent
• Good working knowledge of cGMP and regulatory requirements related to Manufacturing
• Experience with SAP, LIMS, MES systems
• Possess problem-solving and troubleshooting skills
• Rotational shift work is required (12 hours shift)

Mansioni

• Adhere to cGMP and safety requirements
• Execute manufacturing operations including equipment cleaning and set up
• Perform upstream processes: Vial Thaw, Inoculation, Cell Culture and Recovery
• Perform downstream processes: Chromatography, Filtration, Ultrafiltration, Final Filling
• Maintain batch documentation accurately and on time
• Keep inventory levels to minimize distress
• Ensure training is current and applicable
• Support quality, audits, and inspections

Conoscenze

Biotech/Pharma experience

Problem solving

Documentation

Team collaboration

Formazione

Bachelor's degree in Sciences/Engineering

Strumenti

SAP

LIMS

MES

Descrizione del lavoro

• Salary Up to $5,500 depending on experience

About the Job

The Biotechnologist 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

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.

Requirements

• 1-4 years of relevant work experience in Biotechnology / Pharmaceutical industry.
• Degree in Sciences, Engineering, or equivalent.
• Good working knowledge of cGMP and regulatory requirements related to Manufacturing.
• Experience with SAP, LIMS, MES systems.
• Possess problem-solving and troubleshooting skills.
• Rotational shift work is required. (12 hours shift)