Salary: up to 7000
Office Hours 5 Days
Key Responsibilities:
- Production Management: Oversee shift teams to ensure adherence to the production plan and resolve issues as required.
- Manufacturing Expertise: Possess expertise in multiple areas of manufacturing, such as Upstream Processing, Downstream Processing, Equipment Preparation, Buffer Preparation, and key systems like EBM, XFP, CIP, and SIP.
- Audit Support: Act as a subject matter expert during audits, explaining and walking through specific process operations or investigations.
- Deviation Management: Conduct deviation investigations in the GEMS system, including product impact assessments and implementation of CAPAs.
- Change Control: Serve as a change control owner in the CCMS system, if applicable.
- Documentation: Maintain recipe configuration management documentation, if applicable.
- Material Support: Liaise with MLCM or vendors to address material issues, if applicable.
- CAPA Development: Develop and implement CAPAs arising from audits.
- Communication: Inform management of events impacting the production schedule.
- Document Review: Propose and review document revisions.
- Safety: Carry out work in a safe manner, notifying management of safety issues and risks.
Project Management (20%):
- Audit Preparation: Assist in audit preparation and documentation related to audit responses, adverse event notification review, and annual product reviews.
- Process Implementation: Lead the transfer and implementation of new processes, and commissioning and validation activities of new projects.
- Investigation Leadership: Lead complex investigations and continuous improvement initiatives.
- Product Changeover: Lead product changeover activities.
- Parameter Monitoring: Monitor and analyze processing parameters for atypical trends and improvement opportunities.
- Training Coordination: Act as a department training coordinator as required.
Staff Technical Training and Development (10%):
- Training Requirements: Meet and maintain training requirements on time.
- Technical Training: Provide technical training for area personnel and develop training material as required.
- Team Development: Train and coach team members, develop and maintain personal development plans, and participate in site or global strategic initiatives.
- Feedback: Provide feedback to peers to help staff development and conduct annual performance self-assessments.
Compliance:
- EHS Requirements: Adhere to any applicable EHS requirements.
- Code of Conduct: Commit to a fair and respectful relationship with others and behavior in accordance with Code of Conduct.
- Other Duties: Perform any other duties as assigned by the supervisor.
Requirement
- Min. Degree/ Diploma in Chemical Engineering, Bioengineering, Chemical & Biomolecular Engineering, Pharmaceutical Engineering, or related field
- Min.6 years of relevant experience in the biotechnology or pharmaceutical industry.
- Excellent at technical writing as required for Electronic Batch Management (EBM), Batch Records (MBRs, MFRs) and Standard Operating Procedures (SOPs).
- Ideally be Green belt trained/certified and possess good understand of LEAN and Six Sigma concepts
- Full awareness of current Good Manufacturing Practices (cGMP)
- Understanding of requirements from support functions and their capabilities
- Experience as a system user of business systems such as C3ME, XFP and Trackwise
If interested, please email your resume to [email protected]
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Alex Goh Hock Leong
(CEI.No: R1763413 l Recruit Express Pte Ltd (Healthcare & Life Science) | 99C4599)
