Facilities Engineer

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:

An exciting opportunity now exists on our Site for a
Facilities Engineer within our Site Engineering Department.

Reporting to the Site Facilities Lead, as Facilities
Engineer you will be responsible for planning, implementing and maintaining the
infrastructure and equipment of buildings and facility related equipment at the
site. This includes but is not limited to analysis of processes withing the
Facility and Utility Support functions of the Engineering department with a
view to identifying and implementing improvements, supporting ongoing project
activity by participating in safety inspections and walks, participating in
sustainability initiatives and general support to the wider Engineering group.

The ideal person will have prior relevant facility
engineering experience preferably gained in a GMP manufacturing setting with
experience providing support to the Facility and Utility Support functions.

Requirements

Role Functions:

• Collaboration with other departments and our out -sourced
  partners to ensure the successful delivery of the Facility and Utility Support
  function in the safest, most time efficient and cost -effective manner.
  
• Maintain Facility and Utility Support services in the
  context of retaining a permanent inspection readiness state for the site.
  
• Support continuous improvement by active participation in
  projects, system failure studies and incident investigations using recognised
  methodologies such as 8SPS, RCA etc.
  
• Support the development and execution of Change Control
  related to the Engineering function.
  
• Participate in and contribute to Lean measures such as
  Gemba and Kaizen events.
  
• Comply with Global Policies, Procedures and Guidelines,
  regulatory requirements and execute current Good Manufacturing Practices (cGMP)
  in the performance of day -to -day activities and all applicable job functions,
  ensuring consideration of the impact on GMP and compliance and decisions made.
  
• Accountable for compliance via documentation completion,
  risk assessments, closing out corrective actions, participate in audits and
  inspections and proactively highlighting any issues around compliance.
  
• Escalate issues in a timely manner to relevant onsite
  stakeholders and support the resolution of any such issues.
  
• Development of new and review and update of existing
  SOPs.
  
• Support site Reliability and Calibration improvement
  programs.
  
• Collaborate closely with cross functional teams to ensure
  project activity is supported through inspection and safety walks.
  
• Work collaboratively to drive a safe and compliant
  culture .
  
• Collaborate with multiple partners (e.g., IPT, Supply
  Chain, Warehouse, Quality, Labs, Third Parties, Vendors etc).
  
• Drafting presentations and reporting out on progress on
  initiatives to stakeholders as required.
  
• Managing vendors for work on site ensuring compliance
  with safety and permitting requirements for all on site activities.
  
• Responding to safety events, collecting information and
  coordinating investigations and remediation actions.
  
• Responding to building fabric issues, collecting
  information to support investigations and coordinating closure of remediation
  actions.
  
• Supervision of temporary building utilisation and
  responding to issues as they arise.
  
• Overseeing building utilisation and conducting periodic
  occupancy checks.
  
• May be required to perform other duties as assigned.
  

Experience, Knowledge & Skills:

• Considerable experience in a comparable role typically
  gained operating as an independent contributor adding considerable value to the
  business.
  
• Demonstrated ability to deliver on objectives with
  limited oversight.
  
• Experience within Facilities and Utilities support areas
  in a GMP manufacturing environment and have a proven track record in
  identifying and delivering improvement projects.
  
• Knowledge of regulatory/code requirements to Irish,
  European and International Codes, Standards and Practices.
  
• Excellent report, standards, policy writing skills
  required.
  
• Proficiency in Microsoft Office suite and job -related
  computer applications required.
  
• Strong safety ethos.
  
• Proven record of management of change in a commercial
  site.
  

Qualifications & Education:

• Bachelor’s Degree or higher preferred; ideally in an
  Engineering, Science or other technical discipline
  
• Lean Six Sigma Methodology experience desired with Green
  Belt preferred.