Computer System Validation Engineer

PharmEng Technology has been providing quality services to leading manufacturers of healthcare and pharmaceutical products since 1997. Our specialists hold expertise in Commissioning & Qualification, Validation, Quality Systems, Regulatory Affairs, Engineering, and Training to ensure that our clients can keep on providing the world with their cost-effective and high-standard healthcare products. At PharmEng Technology, we strive to cultivate the best working environment where empowerment, passion and perseverance are nurtured while serving our clients to achieve their unique business goals. We are seeking for a Computer System Validation Engineer with experience in pharmaceutical engineering for a role in Singapore.
**Responsibilities**
- Provide technical guidance into the commissioning, qualification and start-up of various equipment and facilities.
- Lead the development of key qualification deliverables during the project lifecycle to ensure 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, FCCA/dRA, DQ, FAT, SAT, IQ, OQ and PQ as appropriate to ensure timely completion and to ensure all quality and engineering specifications are met.
- Prepare protocols, execute protocols, summarize data, resolve deviations, prepare final reports.
- Lead 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.
- Experience with C&Q of upstream or downstream bioprocess systems, or other process equipment, utilities, facilities in pharma, biologics, aseptic fill-finish and API is considered a strong asset.
- Coordinate meetings with cross-functional departments, to drive project progress, facilitate decisions, provide updates.
- Engage other departments, as required, for design reviews and decisions.
- Travel may be occasionally required for meetings with clients, equipment fabricatio 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 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.
- Visit construction and installation sites.
- 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.
- Supervise contractors during critical testing of system and equipment.
- Other duties as assigned by client, and/or PharmEng, based on workload and project requirements.
**Qualifications**
- Excellent written and spoken English is required including the preparation of technical documents in English
- Years of experience: 5 years for years of experience in commissioning, qualification or validation of various systems within the pharmaceutical/biotech industry, where minimum 5 years should include direct C&Q experience with either process automation or building automation systems in the pharma/biotech industry.
- Knowledge of requirements for a cGMP operations, including SOPs, Change Controls, Validation.
- Experience with developing and executing validation projects.
- Risk-Based Commissioning & Qualification approaches, such as ASTM E-2500 or ISPE ICQ, is considered an asset, but not required.
- Knowledge of GAMP and Data Integrity requirements.
- Knowledge of the V-Model for Computer System Validation is required.
- Knowledge of ISA-88 and ISA-95 Standards is considered an asset.
- Experience with commissioning & qualification of either process control systems (i.e. PCS, SCADA, Historians) or building automation systems (i.e. Siemens Insight / Desigo, JCI Metasys) is considered an asset.
- Experience with commissioning and qualification of biotech process equipment (upstream or downstream or both), such as some, but not all, of the following: fermentation, bioreactors, downstream purification processes (chromatography, TFF, UF) is considered an asset.
- Experience with commissioning and qualification of process equipment for aseptic fill-finish and pharmaceutical API and OSD manufacturing processes as well as food/ FMCG manufacturing processes are considered an asset.
- Previous Pharmaceutical/Biotech experience is mandatory for this role.
- Experience with Qualification or Validation of clean utilities, HVAC/ISO clean rooms.
- Experience with thermal Validation is considered an asset.
- Experience with preparation and execution of URS's, DQ's, RTMs, Risk Assessments, CPPs, VPPs, FATs, SATs, IOQs, NCRs,