Metrology Specialist

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.

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