Senior Manufacturing Engineer, APM

3 weeks ago

Singapore MANPOWER STAFFING SERVICES (SINGAPORE) PTE LTD Full time
Roles & Responsibilities

Senior Manufacturing Engineer, APM (URGENT/ Pharma/ API Technology)


Location: Tuas

Up to $10,000 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 - Apple.lim@manpower.com.sg

Recruitment Consultant (R2090579)

Manpower Staffing Services (S) Pte Ltd

EA Licence: 02C3423


Tell employers what skills you have

GxP
CAPA
FMEA
Staffing Services
Manufacturing Processes
Investigation
Cleaning Validation
Productivity Improvement
Reliability
Process Engineering
Technical Training
QHSE
API
Manufacturing
Commissioning

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