Junior Validation Engineer

PSC Biotech® Corporation; Singapore; On-site; SGD 70,000 - 100,000; Full time

Job summary

PSC Biotech Corporation is a leading biotech consultancy providing GMP/compliance services and cloud-based QA software solutions. We seek engineers for on-site, full-time roles supporting top pharmaceutical client sites, with exposure to commissioning, validation, and quality systems.

Ideal candidates hold a related engineering degree and are ready to contribute to change controls, IQ/OQ, SAT, and e-validation activities with a hands-on, collaborative approach in a dynamic global environment.

Qualifications

• Bachelor’s Degree in a related engineering discipline.
• Fresh graduates with strong technical foundations are welcome to apply.

Responsibilities

• Review of P&IDs during commissioning phase.
• Generation of Change control and System Impact Assessment (Kneat).
• Provide SAT support.
• Validation document generation and protocol for equipment, including, but not limited to, process equipment and utility systems, both paper or using e-validation systems (Kneat).
• Execution of IQ and review/support for OQ.
• Closure of Change Control implementation tasks.
• Work independently with the project manager, vendors, and contractors.
• Provide Quality service adhering to SOP requirements.
• Give necessary support for the timely completion of projects.
• Be present on-site to provide full-time support.
• Computerized systems in particular to Agilent LCMS and GCMS.
• Temperature Mapping.
• Cleanroom Qualification.

Skills

P&ID review

Independent work

Quality mindset

Project coordination

Education

Bachelor’s Degree in a related engineering discipline

Tools

Kneat

Agilent LCMS

GCMS

e-validation

Job description

PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia, and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and Regulatory Inspections, pharmaceuticals contract manufacturing professionals, and metrology services to our clients.

‘Take your Career to a New Level’

PSC Biotech disrupts the conventional consultancy model by aligning our EVP as one of the unique selling points which include the opportunity to work with the most talented cohort of like-minded professionals operating in the Pharma/ Biotech Industry. We offer a permanent contract of employment giving exposure to working in Top Pharmaceutical client sites in a diverse cultural work setting.

Employee Value Proposition

Employees are the “heartbeat” of PSC Biotech, we provide unparalleled empowering career development through Learning & Development in-house training mentorship through constant guidance to facilitate career progression. We believe in creating high-performing teams that can exceed our client’s expectations with regard to the quality of all scalable and business unit deliverables, staying under budget, and ensuring timelines for our deliverables are being met.

Key Responsibilities:

• Review of P&IDs during commissioning phase
• Generation of Change control and System Impact Assessment (Kneat)
• Provide SAT support
• Validation document generation and protocol for equipment, including, but not limited to, process equipment and utility systems, both paper or using e-validation systems (Kneat)
• Execution of IQ and review/support for OQ.
• Closure of Change Control implementation tasks
• Work independently with the project manager, vendors, and contractors
• Provide Quality service adhering to SOP requirements
• Give necessary support for the timely completion of projects
• Be present on-site to provide full-time support.
• Computerized systems in particular to Agilent LCMS and GCMS
• Temperature Mapping
• Cleanroom Qualification

Candidate profile:

• Bachelor’s Degree in a related engineering discipline
• Fresh graduates with strong technical foundations are welcome to apply