Instrumentation Engineer

Job Description About PSC Biotech Who we are? 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. Job Title: Instrumentation Engineer   Role Description: Metrology Specialist will be responsible for managing the routine maintenance and calibrations of analytical instrumentation across laboratories and manufacturing suites on site. Requirements Role Functions: ·         Oversee external vendors performing maintenance and calibrations in laboratories and manufacturing areas. ·         Review and approval of data/documentation generated by external vendors. ·         Work in collaboration with area owners, IT, and site services to ensure calibrations are completed on time, in compliance with up-to-date data integrity, regulatory, and industry standards. ·         Perform routine entries in the local calibration maintenance software. ·         Participate in deviations, CAPA’s and change control’s related to the maintenance of instruments in alignment with team priorities. ·         Provide support to maintain a state of permanent inspection readiness for regulatory and internal inspections and audits.   Experience, Knowledge & Skills: ·         Experience working in a GMP regulated environment. ·         Experience and understanding of the change management requirements of validated systems and software. ·         Experience with regulatory audits. ·         Ability to maintain the flexibility to react to changing business needs. ·         Excellent communication skills both verbal and written. ·         Demonstrated ability to drive multiple tasks to completion.   Qualifications & Education: ·         Level 7 or level 8 in Engineering, science, or related field and/or proven work experience as stated. ·         3–5-year relevant experience ·         Preferred experience within the Biotech/Pharmaceutical industry #LI-XA1 Requirements Role Functions: · Oversee external vendors performing maintenance and calibrations in laboratories and manufacturing areas. · Review and approval of data/documentation generated by external vendors. · Work in collaboration with area owners, IT, and site services to ensure calibrations are completed on time, in compliance with up-to-date data integrity, regulatory, and industry standards. · Perform routine entries in the local calibration maintenance software. · Participate in deviations, CAPA’s and change control’s related to the maintenance of instruments in alignment with team priorities. · Provide support to maintain a state of permanent inspection readiness for regulatory and internal inspections and audits. Experience, Knowledge & Skills: · Experience working in a GMP regulated environment. · Experience and understanding of the change management requirements of validated systems and software. · Experience with regulatory audits. · Ability to maintain the flexibility to react to changing business needs. · Excellent communication skills both verbal and written. · Demonstrated ability to drive multiple tasks to completion. Qualifications & Education: · Level 7 or level 8 in Engineering, science, or related field and/or proven work experience as stated. · 3–5-year relevant experience · Preferred experience within the Biotech/Pharmaceutical industry