Pharma Life Cycle Management Engineer (CSV/Automation)

About the role

A leading U.S.-based biopharmaceutical company, represented by Manpower, is looking for a Life Cycle Management Engineer for its Tuas site in Singapore. The role covers the full life cycle of computerized systems, from design and installation through qualification to retirement, and focuses on Computer System Validation (CSV) and automation. It is a 12-month contract with salary up to $7,000 depending on experience.

Key responsibilities

• Take part in end-to-end life cycle phases of computerized systems, from design, installation and qualification to retirement.
• Understand the development of CSV and equipment specifications.
• Write Commissioning and Qualification (C&Q) protocols and retirement plans.
• Execute CSV, SDLC and commissioning/validation activities (IQ, OQ, PQ) in line with GAMP, local SOPs and industry guidance.
• Assess the impact of changes to cGMP equipment and systems and set the validation plan so validated status is maintained.
• Produce technical writing and reports on testing methodologies of automated systems, and evaluate validation protocols and summary reports.
• Write, review and revise installation, operation and performance qualification documents such as SOPs, master plans, guidelines and execution plans.
• Deliver C&Q work on schedule, track progress and coordinate with project contractors and equipment vendors.

Required profile

• At least 1 year of experience in automation, computer system validation, qualification and commissioning.
• Experience in the pharmaceutical industry.

Required skills

• Automation such as Siemens/Rockwell PLC and HMI development.
• Validation of equipment controlled by PLCs, BAS/BMS systems, DeltaV and other automated platforms.
• Understanding of testing and software development lifecycle and QA methodologies.