MSD Associate Director Engineering Pharmaceutical Technical Operations 

Singapore, Singapore 

752884067

Job Description

Key Responsibilities:

• Technical Oversight: Lead, mentor, and coach the pharmaceutical technical operations (PTO) team in their technical support activities, including investigations, product and cleaning validations, compliance audits, process monitoring, and requalification. Provide leadership in driving resolution of complex investigations for deviations and customer complaints.

• Process Improvement: Drive continuous process improvement initiatives to enhance process robustness, cycle time reduction, cleaning efficiency, yield optimizations, alternate source qualifications etc. Able to utilize digital and statistical tools for proactive process analysis monitoring.

• Regulatory Compliance: Maintain a deep understanding of current regulatory guidance including EU Annex 1. Provide ongoing technical support during regulatory audits and ensure adherence to Quality Management System (QMS) topics pertinent to PTO operations.

• Team Leadership and Development: Manage a team of engineers by setting priorities and developing individual career development plans. Foster an inclusive work environment that emphasizes professional growth, collaboration, and technical excellence.

• Technical Expertise: Act as the subject matter expert (SME) for sterile fill-finish unit operations, process engineering and process design. Ensure successful implementation of new technologies and practices that enhance operational robustness and cost efficiency.

• Cross-Functional Collaboration: Work closely with cross-functional teams including Biotech Integrated Production Team (IPT) and other site groups, to align priorities, share best practices, and drive strategic initiatives aimed at business transformation and risk mitigation. Support strategic initiatives activities to enhance site performance metrics and provides expert knowledge to the site and across our company global technical network (while leveraging on other site experiences/ knowledge).

• Safety Leadership: Uphold and promote Environmental, Health & Safety (EHS) standards by participating in safety walks, process hazard analyses, and ensuring compliance throughout all operations.

• Documentation and Compliance: Oversee the writing and review of SOPs, gap analyses, and job aids to ensure compliance with corporate policies and guidelines.

Ideal Candidate Profile:

• Proven experience in sterile fill/finish manufacturing and process development.

• Strong leadership skills with a demonstrated ability to coach and develop teams.

• Extensive knowledge of compliance standards and regulatory requirements in the pharmaceutical industry.

• Ability to leverage industry best practices to enhance operational processes.

• Proficiency in problem-solving and statistical analysis tools.

Qualification:

• Bachelors, Masters or Ph.D. degree in a technical field, including Chemical or Mechanical Engineering, Chemistry or Pharmaceutical Sciences.

Experience:

• Minimum 8 years technical experience in related pharmaceutical manufacturing industry

• Minimum 2 years in supervisory position of professional staff and/ or demonstrated capability to successfully lead large teams in complex projects.

• Expert knowledge of core technology/unit operations relevant to Biotech and/or related Sterile manufacturing.

What we look for

Current Contingent Workers apply

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