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 PropositionEmployees 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:Our site are excited to offer a fantastic Engineering
Specialist (Validation) opportunity for candidates interested in a new
challenge in a cGMP regulatory environment. The successful candidates will
support several aspects of Validation. The roles available that will require experienced, energetic and
committed engineers are in the following areas:Sterilisation – Autoclaves, SIP of vesselsCleaning – Parts Washer and CIP of vesselsIsolator (Filling, Sterility & Material Transfer
isolators) - HVAC, VHP, E-Beam and Depyrogenation systemsControlled Temperature Units (CTU) – Temperature/Humidity
MappingFilter ValidationContainer Closure Integrity Validation Shift Pattern: Candidates must be flexible to be available to work shifts as
may be required (2 Cycle 5 days a week: 7am-3pm and 3pm-11pm)RequirementsRole Functions:Design/Author/Review/Approve/Execute
qualification/validation documentation and cycle development studies in line
with the standard approval process.Design/Author/Review/Approve/Execute
Execution/development of change controls.Resolving technical issues encountered during study
execution.Engagement with Production, Maintenance and Quality
representatives in the assigned area of operations during execution of Cycle
Development & Performance Qualification activities.Technical input into quality notification by
authoring/reviewing/approving investigations.Perform root cause analysis of system failures,
substandard performance, using standard tools and methods, to resolve machine
and system issues.Support continuous improvement through Lean Six Sigma
methodologies.Serve as validation representative for cross functional
projects and represent the validation team at global technical forumsDrive compliance of 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, participation in audits and
inspections and proactively highlighting any issues around complianceSupporting regulatory audits and submissions as required.Work collaboratively to drive a safe and compliant
culture.May be required to perform other duties as assigned. Experience, Knowledge & Skills:In order to excel in this role, you will more than likely
have considerable experience in a comparable role, with experience operating as
individual contributor adding value to the business in a GMP manufacturing
setting, as well as the following qualifications/skills:Relevant technical qualification(s) in Applied
Pharmaceutical / Biological / Chemical sciences or applied Technical /
Engineering qualification, the successful candidate will also have a proven
track record in delivering excellence.Knowledge of CTU equipment qualificationKnowledge of thermal mapping equipmentThermal mapping skillsException / Deviation Management and Change Control.Demonstratable experience of leading technical related
projects.Knowledge of process monitoring systems, automation
systems (DeltaV), operational intelligence & data systems (Pi System)
within a GMP manufacturing environment would be beneficial and desirableEvidence of continuous professional development is
desirable.Knowledge of regulatory/code requirements to Irish,
European and International Codes, Standards and Practices.Ability to analyse and interpret complex data, and link
to equipment performance and out of specification findings as appropriate.Report, standards, policy writing skills required.Equipment and process validation.Sterile Fill-Finish processes and equipment.Proficiency in Microsoft Office and job-related computer
applications requiredExcellent communication, presentation and interpersonal
skills, to interface effectively with all levels of colleagues and with
external customers in a team orientated manner. Knowledge and experience of the below areas will be
considered advantageous:Equipment Periodic ValidationEquipment Validation LifecycleProject Management Skills/QualificationFilter Validation & Container Closure ValidationAutoclave/SIP Sterilisation ValidationDry Heat SterilisationIsolator QualificationVial and Syringe Processing TechnologiesTemperature MappingCleaning ValidationThe successful candidate will be required to work both
independently and in a cross-functional team to accomplish validation project
objectives. Works with moderate work direction and is skilled and knowledgeable
to the position. Qualifications & Education:Relevant Degree level, Technical qualification(s) in
Applied Pharmaceutical / Biological / Chemical sciences or applied Technical /
Engineering qualification, the successful candidate will also have a proven
track record in delivering excellence.#LI-AP1