Senior Process Engineer/Chemist
- Based in Singapore, the regional hub for Asia Pacific (AP) and top-ranked biopharmaceutical company on the Straits Times and Statista’s list of Best Employers in Singapore for two consecutive years (2020, 2021).
- Join the premier biopharmaceutical company that has been in Singapore for more than 25 years and in AP for over 60 years.
The Senior Process Engineers/Chemists support the Lead in introducing new products to the site, providing technical expertise on the manufacture of all drug products on site and transferring drug products to other facilities. In collaboration with supporting functional groups, they provide technical guidance on deviations, investigations and customer complaints. They also support continuous process improvement activities to enhance site performance metrics and contributes to global technical networks to share site experiences and expand on personal and site expertise
WHAT YOU WILL DO
Responsibilities include, but are not limited to:
- Supports new product introductions to the site by assisting with process and equipment comparisons, new raw material introduction, development studies, cleaning; processes development and validation and process fit and gap analysis.
- Supports filing activities by assisting with process qualification activities, equipment qualification and cleaning validation. Expected to have a working knowledge of QMS and understands the principles of Quality by Design (QbD) and executes the requirements in support of a QbD filing
- Supports routine supply manufacture by providing on going technical support to the IPT and proactively monitoring the performance of equipment/module(s) or unit operation(s) during manufacturing and cleaning. Responds to shifts and trends in performance appropriately and based on the data identifies opportunities for improvement.
- Change owner for process Global Change Management (GCM) change controls.
- Participates in developing continuous process verification (CPV) plans and contributes to the CPV reports and annual product reviews. Conversant in statistical analysis.
- Provides technical expertise related to equipment and manufacturing/cleaning processes in response to deviations to understand and eliminate the root cause(s)
- Leads investigations for non-emergency product complaints and deviations using problem solving tools such as KT. Ishikawa, FMEA, 5 Whys.
- Actively participates and show commitment to collaboration and sharing of best practices with internal/external subject matter experts (SMEs) (e.g. CPDC, PCT, Sterile council, ADC, CMSE and other groups within the GSTC network.
- Complies with all divisional and site-specific policies, guidelines and procedures. Making safety adherence as a pre- requisite to employment.
- Demonstrates and promotes safety, health & environment leadership behaviour, ensuring that all activities are carried out in accordance with requirements. Actively participates in GEMBA safety walk, HazOp. Speak on process safety and lead by example safety commitments.
- Where applicable, develops SOPs, gap analysis and Job Aids for Subsystems in compliance with divisional and corporate policies and guidelines
- Leads personal career development with manager assistance through annual Performance Management Process (PMP),
- Employee Development Plan (EDP) and career mapping
- Any other duties as assigned by the Supervisor.
WHAT YOU MUST HAVE
To be successful in this role, you will have:
- Bachelors, Masters or Ph.D. degree in a technical field, including Chemical or Mechanical Engineering, Chemistry or Pharmaceutical Sciences
- Minimum 5-7 years of technical experience in API manufacturing
We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace
