Pharmaceutical – AUTOMATION CSV ENGINEER
7 days ago
MMR Consulting WP. Kuala Lumpur, Federal Territory of Kuala Lumpur, Malaysia
MMR Consulting is an engineering and consulting firm specializing in the pharmaceutical and biotechnology industries. Its services include Engineering, Project Management, and Validation. MMR has offices in Canada, USA, India, Singapore, and Australia.
This is an outstanding opportunity to join our growing team, where the successful candidate will work with a group of engineers and specialists involved in project management, commissioning, and qualification of equipment, systems, and facilities.
This role is for an Automation CSV Engineer to work on the commissioning, qualification, and startup of Automation systems in the pharma/biotech industry, such as Process Controls and Building Automation. The ideal candidate should possess leadership skills to lead/mentor junior engineers. The work is onsite at one of our clients in Singapore.
Responsibilities
- Provide technical guidance into the commissioning, qualification, and start-up of Automation systems.
- Lead the development of key qualification deliverables during the project lifecycle to ensure the project is well defined, and the action plan to test the system is applicable and relevant.
- Lead qualification processes throughout the project lifecycle such as VPP, Risk Assessments, RTM, DQ, FAT, SAT, IQ, OQ, and PQ as appropriate to ensure timely completion and to ensure all quality and engineering specifications are met.
- Experience with C&Q of either Process Controls (i.e. DCS, PLCs, SCADA/Historians) or Building Automation Systems (i.e. Siemens Insight / Desigo, JCI Metasys) is required.
- Coordinate meetings with cross-functional departments to drive project progress, facilitate decisions, and provide updates.
- Engage other departments, as required, for design reviews and decisions.
- Travel may be occasionally required for meetings with clients, equipment fabrication vendors, or Factory Acceptance Testing (FATs).
- Work may require occasional support over shutdowns or extended hours, specifically during installation and commissioning/validation phases.
- Client management (maintain key Client relationships in support of business development and pursuit of new work), project scheduling/budgeting, coordination of client and MMR resources for effective project delivery, supporting business development (providing technical support to the sales as required for proposals/opportunities), presenting at industry conferences/publishing papers etc.
- As this position requires working on client sites, you will need to comply with the client's safety rules including mandatory vaccination policies for COVID-19, where applicable.
- Visit construction and installation sites.
- Supervise contractors during critical testing of systems and equipment.
- Other duties as assigned by client and/or MMR, based on workload and project requirements.
Qualifications
- Education: Bachelor's degree in electrical, Instrumentation, or Automation Engineering.
- Experience: 6-10 years in Delta V Emerson DCS commissioning & qualification (C&Q). Experience with validation of other automation systems is an asset but not required (SCADA, Historian, MES, PLC).
- Automation/Programming experience is an asset but not required: DeltaV DCS, SCADA, PLCs (Allen Bradley, Siemens, etc.), and historian systems.
- C&Q Expertise: Proficient in IQ, OQ, and PQ protocol development and execution.
- Regulatory Compliance: Knowledge of GAMP 5, 21 CFR Part 11, and CSV.
- Documentation & Communication: Strong technical writing and collaboration skills.
- Travel may be required on occasion.
- Mid-Senior level
- Full-time
- Manufacturing
- Pharmaceutical Manufacturing
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