Senior Manufacturing Engineer, APM (URGENT/ Pharma/ API Technology)
Full-time
Senior Executive
2 days ago
Senior Manufacturing Engineer, APM (URGENT/ Pharma/ API Technology)
Location: Tuas
Up to $8,000 depending on experience
Industry: Pharmaceutical
IMME..
Senior Manufacturing Engineer, APM (URGENT/ Pharma/ API Technology)
Location: Tuas
Up to $8,000 depending on experience
Industry: Pharmaceutical
IMMEDIATE VACANCY
Our client aims at creating a new manufacturing concept consisting of a new generation of evolutive multi-product facilities, modular, adaptable, and agile, leveraging new disruptive technologies, to better address vaccine business challenges.
Job Summary:
- Responsible for designing, implementing, and reviewing the procedures involved in manufacturing processes.
- Establishes procedures and proper documentation control as well as performs risk analysis and HAZOPs to ensure that safety, quality, delivery and productivity goals are fulfilled.
- Conducts or participates in productivity improvement activities including equipment/fixture selection, design and commissioning.
- This role is integral in driving continuous improvement processes, utilizing problem-solving techniques, and ensuring that operations align with company goals and standards.
Responsibilities:
- Support all API manufacturing activities to deliver to the business production plan, while ensuring compliance with QHSE standards.
- Liaise with Process & Technology department and Engineering Maintenance department to ensure the design of appropriate process/ engineering modifications for the continuous improvement activities/ operational yield improvement initiative for the manufacturing department/ facilitate the introduction of new products.
- Lead the change management process for continuous improvement; plant modification and improvement projects, validation planning and cost-saving projects and equipment qualifications including generating the appropriate documentations (IQ, OQ and PQ).
Other Activities:
- Work with all the support function to lead/ facilitate any trouble shooting activities resulting in timely closure of investigation and CAPA using problem solving tools such as Ishikawa, FMEA, 5 Whys
- Ensure accountability and commitment in achieving the goals of continuous improvement of Safety performance through participation/ leading in HAZOPs.
- Create, review and revise manufacturing documents such as batch records, SOPs, etc. to meet cGMP and safety compliance.
- Perform gap and technical assessments for global standards and procedures (GSPs and SOPs).
- Serve as risk lead or subject matter expert in support of risk assessments and hazards analysis e.g. microbial control risk assessments
- Develop technical training material and conduct technical training for production staff. To train and coach production team on the equipment and process. As a Key point of contact for any equipment or production issues.
- Develop technical reports and engineering documents such as URS, FS, P&IDs, etc. Support performance of reliability study of equipment.
- Ensure company life savings rules are understood and applied and being proactive in identifying, addressing and resolving issues in a timely manner.
- To support/lead internal and external quality and HSE compliance audits.
- Develop cleaning validation strategy.
- Perform simple use test in laboratory to assist in deviation investigation.
- Contribution to continuous improvement loops:
- Power continuous improvement loops with problems encountered and use problem-solving techniques to identify root causes
- Have the appropriate level in problem solving, e.g. GPS3, to be able to effectively coordinate problem solving groups and ensure the use of appropriate tools.
Requirements:
- Bachelor’s Degree In Chemical Engineering or equivalent.
- Minimum of 5 to 7 years of pharmaceutical or industrial manufacturing experience.
- Ability to quickly know products and processes to assess performance issues.
- Good knowledge of GxP requirements and regulations.
Lim Pey Chyi - [email protected]
Recruitment Consultant (R2090579)
Manpower Staffing Services (S) Pte Ltd
EA Licence: 02C3423
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