Capital Specialist- Level 1

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.

Job Purpose

The role of the Capital Specialist is to ensure the
day-to-day installation and decommission of all laboratory instruments,
minimizing any downtime in the Laboratory. The role covers Drug Substance and
Drug Product instrumentation in clinical and commercial areas for ADC.  The Capital Specialist also has
responsibilities for management of Analytical equipment installation and
decommissions in the CDS department.

Requirements

Principal Accountabilities:

• The Capital Specialist has overall responsibility for
  installing and decommission Laboratory Instrumentation in ADC/CDS.  The Capital Specialist will complete
  installation and decommission activities and use external support as required
  to meet customer targets.
  
• The Capital Specialist is responsible for ensuring all
  Capital installs and decommissioning comply with cGMP, including acting as
  auditee for this area. The Capital Specialist assures compliance with all
  safety and environmental requirements. Compliance with other regulated areas
  such as trade compliance, human resources and spending are also
  responsibilities of the role for this scope of work.
  
• Installs all instrumentation in accordance with laboratory
  validation policies, procedures, and guidelines.  Reviews and approves validation activities
  for instrumentation as required. Responsible for the decommissioning of
  instruments as appropriate.
  
• Ensures that all instruments are released in a validated
  state and setup on a site equipment asset management system so they can be
  maintained on a PM/PV schedule.
  
• Responsible for troubleshooting issues with during
  installation, ensuring that investigations are raised, investigated, and closed
  out as required and for coordinating with vendor service engineers to come on
  site.
  
• Ordering and installing new laboratory equipment,
  ensuring associated documentation is in accordance with  SDLC (System Development Life Cycle).
  

Special Features

• The incumbent operates as part of a team and is
  self-directed team in carrying out day-to-day activities.
  
• On assignment, the incumbent participates in departmental
  initiatives on improved compliance and quality systems.
  

Core Competencies

Technical:

• Policies and guidelines
  
• Plant documentation
  
• Laboratory testing and documentation
  
• Validation principles and guidelines
  
• Computer skills
  
• System Development Life Cycle
  

Business:

• Project Management.
  

Leadership:

• Communication skills both written and oral
  
• Team and interpersonal skills
  
• Technical report writing
  
• Time Management
  
• Meetings Management
  
• Analytical Problem-solving skills
  
• Planning and Scheduling
  

Educational Requirements:

• BSc. (or equivalent experience base) in analytical
  chemistry, pharmaceutical science or a related discipline.
  

Additional Notes:

• Start Date: January
  
• Team Structure: 4 Capital Teams
  
• Business Reason: The business requires additional
  resources to meet site demands for instruments being installed across the ADC
  and CDS labs.
  
• Overtime: Not required
  
• Travel: No travel required
  
• Shift Pattern: Standard shift pattern, days only
  
• Work Location: Onsite
  
• Submission Deadline: 8 October at 12:00 PM
  
• Candidate Profile: Preference for candidates with
  stronger/more extensive experience, particularly with the SDLC lifecycle and
  similar technologies.
  
• Interview Process: Onsite interview with the Hiring
  Manager, following CV review.