* Industry Pharma/Biotech/Clinical Research
* Work Experience 4-5 years
* City Carlow
* State/Province Carlow
* Country Ireland
Job Description
About PSC Biotech
Who are we?
PSC Biotech is a leading Biotech Consultancy firm foundedin 1996, headquartered in Pomona, California, USA, with Global operations inIreland, India, Singapore, Australia and the US, serving 350 clients in morethan 23 countries worldwide. We provide cloud-based software solutions forQuality Management and Regulatory Inspections, pharmaceuticals contractmanufacturing professionals, and metrology services to our clients.
‘Take your Careerto a new Level’
PSC Biotech disrupts the conventional consultancy modelby aligning our EVP as one of the unique selling point which includes theopportunity to work with the most talented cohort of like-minded professionalsoperating in the Pharma/ Biotech Industry. We offer a permanent contract ofemployment giving exposure of working in Top Pharmaceutical client sites in adiverse-cultural work setting.
Employee ValueProposition
Employees are the “heartbeat” of PSC Biotech, we provideunparalleled empowering career development though Learning & Developmentin-house training mentorship through constant guidance to facilitate careerprogression. We believe in creating high performing teams that can exceed ourclient’s expectations with regards to quality of all scalable and business unitdeliverables, staying under budget and ensuring timelines for our deliverablesare being met.
Overview:
* An exciting opportunity now exists on our Site for aFacilities Engineer within our Site Engineering Department.
* Reporting to the Site Facilities Lead, as FacilitiesEngineer you will be responsible for planning, implementing and maintaining theinfrastructure and equipment of buildings and facility related equipment at thesite. This includes but is not limited to analysis of processes within theFacility and Utility Support functions of the Engineering department with aview to identifying and implementing improvements, supporting ongoing projectactivity by participating in safety inspections and walks, participating insustainability initiatives and general support to the wider Engineering group.
* The ideal person will have prior relevant facilityengineering experience preferably gained in a GMP manufacturing setting withexperience providing support to the Facility and Utility Support functions
* Some flexibility on WFH occasionally
Requirements
Role Functions:
* Collaboration with other departments and our out-sourcedpartners to ensure the successful delivery of the Facility and Utility Supportfunction in the safest, most time efficient and cost-effective manner.
* Maintain Facility and Utility Support services in thecontext of retaining a permanent inspection readiness state for the site.
* Support continuous improvement by active participation inprojects, system failure studies and incident investigations using recognisedmethodologies such as 8SPS, RCA etc.
* Support the development and execution of Change Controlrelated to the Engineering function.
* Participate in and contribute to Lean measures such asGemba 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 andinspections and proactively highlighting any issues around compliance
* Escalate issues in a timely manner to relevant onsitestakeholders and support the resolution of any such issues.
* Development of new and review and update of existingSOPs.
* Support site Reliability and Calibration improvementprograms.
* Collaborate closely with cross functional teams to ensureproject activity is supported through inspection and safety walks.
* Work collaboratively to drive a safe and compliant culture
* Collaborate with multiple partners (e.g., IPT, SupplyChain, Warehouse, Quality, Labs, Third Parties, Vendors etc).
* Drafting presentations and reporting out on progress oninitiatives to stakeholders as required.
* Managing vendors for work on site ensuring compliancewith safety and permitting requirements for all on site activities.
* Responding to safety events, collecting information andcoordinating investigations and remediation actions.
* Responding to building fabric issues, collectinginformation to support investigations and coordinating closure of remediationactions.
* Supervision of temporary building utilisation andresponding to issues as they arise.
* Overseeing building utilisation and conducting periodicoccupancy checks.
* May be required to perform other duties as assigned.
Experience,Knowledge & Skills:
* Considerable experience in a comparable role typicallygained operating as an independent contributor adding considerable value to thebusiness.
* Demonstrated ability to deliver on objectives withlimited oversight.
* Experience within Facilities and Utilities support areasin a GMP manufacturing environment and have a proven track record inidentifying and delivering improvement projects.
* Knowledge of regulatory/code requirements to Irish,European and International Codes, Standards and Practices.
* Excellent report, standards, policy writing skillsrequired.
* Proficiency in Microsoft Office suite and job-relatedcomputer applications required.
* Strong safety ethos.
* Proven record of management of change in a commercialsite.
Qualifications& Education:
* Bachelor’s Degree or higher preferred; ideally in anEngineering, Science or other technical discipline
* Lean Six Sigma Methodology experience desired with GreenBelt preferred.
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