Facilities Engineer - Carlow, Ireland - PSC Biotech Ltd

Description

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: Facilities Engineer

Role Description:

· 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.

#LI-EL1

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. #LI-EL1