Senior Engineer, Manufacturing, APM

Job title: Senior Engineer, Manufacturing, APM

Location: Singapore

Hiring Manager: Head of Production

About the job

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families.

Job Purpose

The Senior Engineer, Manufacturing is responsible fordesigning, implementing, and reviewing the procedures involved in manufacturing processes. He/ She 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. He/ She 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.

Reporting Relationship

• Reporting to the Head of Production and a member of the Production team.

Key Accountabilities

Main 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 fit/ 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 Sanofi life savings rules are understood and applied and being proactive in identifying, addressing and resolving issues in a timely manner.
• To support/leadinternal 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.

Contact with Others

Internal - Local staff (all departments)

External - Overseas regulatory authorities

- Local authorities

- Suppliers / Vendors

- Business and technical partners

About You

• 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.
• Demonstrates the highest levels of integrity and a strong work ethic.
• Good knowledge of GxP requirements and regulations.
• Possess analytical skills and critical thinking skills with the ability to solve problem and navigate through complexity and ambiguity. Good level of decision making and problem solving.
• Good planning and scheduling skills.
• Self-starter and independent who can work and perform in cross functional teams and across shift teams.
• Good communication skills both verbal and written. Good interpersonal skill and technical writing skills.
• Able to work in fast paced and dynamic conditions with tight deadline.