MSD Senior Process Engineer/Chemist 

Singapore, Singapore 

703136581

Job Description

Senior Process Engineer/Chemist

• Based in Singapore, the regional hub forAsia Pacific (AP)andtop-ranked biopharmaceutical company on the Straits TimesandStatista’s list of Best Employers in Singapore for two consecutive years (2020, 2021).
• Join thepremier biopharmaceutical companythat has beenin Singapore for more than 25 years and in AP for over 60 years.

WHAT YOU WILL DO

• 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 andmanufacturing/cleaningprocesses 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

Current Contingent Workers apply

*A job posting is effective until 11:59:59PM on the dayBEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the dayBEFOREthe job posting end date.

A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.