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Senior Technical Specialist

1 month ago

Singapore NO DEVIATION PTE. LTD. Full time

We are seeking a highly skilled Senior Technical Specialist to join our team at NO DEVIATION PTE. LTD.

About the Role

This is an exciting opportunity for a technical expert to drive process equipment performance and operation across our pharmaceutical manufacturing site. As a Senior Technical Specialist, you will be responsible for ensuring the safe, compliant, and sustained operation of our process equipment.

Key Responsibilities
  • Support NPI and Site projects as Engineering Technical Lead or Subject Matter Expert for process equipment.
  • Provide technical expertise in site selection assessment to identify equipment/facility gaps, select new equipment, assess layout/utilities capacity, and partner project managers to develop project cost and schedule.
  • Perform assessments for equipment during new product introduction, change controls, and other qualifications activities to ensure equipment is in its validated state.
  • Subject matter expert for process equipment performance and operation to ensure safety, compliance, and sustained operation.
  • Lead and participate in technical transfer activities and cross-functional meetings.
  • Work independently and/or with project managers to complete engineering projects of various scales within schedule, budget, and quality constraints.
  • Effectively manage and work with project CQV teams to ensure timely delivery of projects.
  • Responsible for commissioning and qualification activities, including FAT, SAT, PSSR, automation checkouts, IQ, OQ, PQ, and asset/preventive maintenance/spare parts creation for new process equipment.
  • Participate in system walk-downs, ensure the closure of punch items, and support the takeover of the system from the project team.
  • Work closely with project managers to introduce new equipment, including development of business cases, project charters, user requirement specifications, quality risk assessments, conceptual designs, preliminary designs, design specifications, and detail designs.
  • Participate in design reviews and set up new assets and associated maintenance plans/spares in Maximo.
Requirements
  • Doctorate degree in Engineering OR Master's degree in Engineering and 4 years of directly related experience in a pharmaceutical manufacturing site OR Bachelor's degree in Engineering and 8 years of directly related experience in a pharmaceutical manufacturing site.
  • Able to work independently with minimal/no supervision.
  • Experience in managing various stakeholders' expectations related to process equipment in biopharmaceuticals.
  • Good communication skills, both oral and written, including presentation skills.
  • Strong analytical skills and knowledge of industry trends to identify potential improvement opportunities.
  • Working knowledge of biopharmaceutical processes such as chromatography, buffer/media tanks, viral filtration, tangential flow filtration is preferred.
  • Process knowledge on inoculation, bioreactors, harvest, single-use technologies, and critical utilities will also be considered.

The estimated salary for this role is SGD $120,000 - $180,000 per annum, depending on experience.

No Deviation PTE. LTD. offers a competitive compensation package, comprehensive benefits, and opportunities for professional growth and development.