Full job description
Process Automation team (On-site) to work on the design, project execution and commissioning of process systems in the biopharmaceutical industry. This position requires experience relating to Pharmaceutical and/or Biotech. This position will require candidate with leadership skill to lead/ mentor junior engineers, equipment vendors and contractors.
Responsibilities
- Provide technical guidance into the design, project management, commissioning and start-up of automation systems, for upgrades, renovations and expansions of client facilities and processes.
- Support project execution from Feasibility through to project completion/handover, including all project stages such as:
- Feasibility
- Concept Design, Basic Design, Detailed Design
- Procurement
- Construction
- Project Monitoring/Governance
- Commissioning & Qualification
- The ideal candidate has experience in Distributed Control Systems (DCS) such as Emerson DeltaV, Siemens PCS7, Yokogawa Centum and preferably has experience in SCADA/Historians, specifically within process controls in biopharmaceutical industry.
- Prepare/perform/review electrical drawings, such as Panel Drawings, wiring diagrams, single line drawings.
- Perform programming/ configuration on PLCs, DCS or SCADA/Historians.
- Review programming of equipment vendors and other automation firms.
- Perform automation/ electrical troubleshooting on electrical panels and control systems.
- Familiarity with ISA 88/ 95 Standards for automation.
- Facilitate work efforts with other disciplines such as Process Engineering, Mechanical, Validation, and client’s internal stakeholders.
- Prepare/review User Requirements Specifications (URS), Functional Requirements, Specifications (FRS), SDS, DDS, Valve & Alarm Matrices.
- Provide input into Commissioning (FAT, SAT) and Qualification Protocols (IQOQ), as well as support execution of Commissioning & Qualification.
- Experience with, and knowledge of some of the typical Biotechnology processes & peripheral systems is required; Upstream Biotech Processes (Fermentation, Bioreactors, Centrifugation, Thawing), Downstream/ Purification Biotech Processes (chromatography, TFF, DF, NF-MF), Fill & Finish equipment, Media Preparation, CIP/SIP systems, Buffer Preparation, clean utilities (PW, WFI, CS, PS)
- Facilitate project management tools throughout the execution of projects, such as procurement tracking, vendor management, meeting minutes/ action lists, risk register log, schedule updates, project updates.
- Coordinate meetings with cross-functional departments, to drive project progress, facilitate decisions, provide updates.
- Work may require occasional support over shutdowns or extended hours, specifically during installation and commissioning / validation phases.
- Required to comply with the safety rules including mandatory vaccination policies for COVID-19, where applicable.
- Supervise contractors during critical installations of process equipment and associated duties.
- Other duties as assigned, based on workload and project requirements.
Qualifications
- Excellent written and spoken English is required including the preparation of technical documents in English.
- Knowledge of GMP requirements for working in pharma/biotech facilities, with a Basic understanding of SOPs, Validation, Change Controls.
- Detailed knowledge of GAMP and its application to large- and small-scale systems.
- Detailed knowledge of data integrity requirements.
- At least 10 years of experience in pharma process automation engineering experience, with at least 8 years’ experience respectively in process controls with DCS / SCADA / Historians with upstream or downstream bioprocesses.
- Ability to read electrical drawings, PLC code, DCS code.
- Ability to perform programming/configuration of Emerson DeltaV DCS, Siemens PCS7 etc.
- Possess leadership skills, and be able to take initiative to lead projects, involving multiple stakeholders, departments, and varying complexity.
- Possess mentorship skills, to coach and develop junior employees.
- Engineering degree, preferably in Isntrumentation, Electrical, Electromechanical, Controls, Chemical, Mechanical Engineering or a related discipline.
