About PSC Biotech
Who are we?
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 point which includes 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 of 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 though 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 regards to quality of all scalable and business unit deliverables, staying under budget and ensuring timelines for our deliverables are being met.
Overview:
Reporting to the Engineering Coach the calibration and Validation engineer enables the safe, compliant and reliable manufacture of live vaccine by executing calibration, verification and maintenance of measurement and test equipment across production, laboratory and facility systems on site.
Requirements
Role Functions:
* Perform scheduled and unscheduled calibrations and verifications of process, lab and facility equipment
* Conduct field and bench calibrations; update calibration records
* Investigate out-of-tolerance events, support root-cause analysis and corrective actions
* Maintain traceability to national/international standards and manage reference standards; coordinate third-party calibrations
* Support installation, commissioning and validation of new instruments and process equipment
* Liaise with QA, Production and Maintenance to schedule calibrations with minimal downtime
* Maintain calibration tools, spares and controlled documentation; propose improvements to procedures and workflows
* Experience, Knowledge & Skills:
* Practical experience in pharmaceutical, biotech, medical device or other regulated manufacturing environments preferred
* Experience performing field and bench calibrations on process, laboratory and facility instruments
* Experience using calibration management systems/CMMS
* Solid understanding of calibration principles, measurement uncertainty and traceability to national/international standards (e.g., NIST or equivalent)
* Familiarity with GMP/cGMP requirements, ISO 17025 concepts and controlled documentation practices
* Working knowledge of process and laboratory instrumentation: pressure, temperature, flow, level, pH/DO probes, balances, multimeters, HVAC/environmental sensors, data loggers, sterilization indicators
* Basic awareness of instrument commissioning, validation/qualification activities and root cause analysis for out of tolerance events
* Strong practical calibration skills (field and bench) and accurate record keeping
* Competency with CMMS/calibration software and MS Office (Excel, Word)
* Good troubleshooting and analytical problem solving abilities
* Attention to detail and high standards for data integrity and documentation
* Effective communication and teamwork; ability to liaise with QA, Production and Maintenance
* Organisational skills and ability to prioritise tasks in a dynamic manufacturing environment
Qualifications & Education:
* Qualification: Level 6/7 apprenticeship, Higher Certificate, National Diploma or equivalent in Instrumentation, Mechatronics, Engineering or related field (or equivalent experience)
* Experience: 7+ years in calibration/instrumentation/metrology; pharmaceutical/biotech experience preferred
* Skills: calibration principles, uncertainty and traceability; hands-on with process and lab instruments; familiarity with GMP/ISO 17025 concepts; competency with CMMS/calibration software and MS Office
* Desirable: PLC/HMI knowledge, calibration/metrology certification, GMP and ISO 17025 awareness, electrical safe isolation training