PSC Biotech Corporation
Cork city, Ireland | Posted on 12/19/2025
Industry Pharma/Biotech/Clinical Research
City Cork city
State/Province Cork
Country Ireland
Job Description 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.
The
Specialist, Engineering,MS&T, Q&V
will be an active member within the cross functional team providing support and guidance and will strive for technical excellence to ensure the success of the Q&V team.
Responsibilities
Lead/Execute/Participate in Equipment and System Validation Lifecycle processes, Qualification (IQ/OQ/PQ), Revalidation, Requalification and Equipment Periodic Reviews, for Equipment and Systems.
Coordinate with and guide other departments or outside contractors/vendors to complete validation tasks.
Participate in CSV Validation Lifecycle processes, Qualification (RS/QAP/UAT etc), CSV Periodic Reviews, for Equipment and Systems.
Participate and comply with the Manufacturing Division Quality Management System (QMS) requirements, including ownership, as relevant.
Investigate and troubleshoot problems which occur and determine solutions or recommendations for changes and/or improvements.
Execute/Participate in change controls and other compliance related tasks e.g. non‑conformances.
Support regulatory audits.
Lead/Support Shipping Qualification and/or Cleaning Verification/Validation activities.
Work on own initiative to maintain adherence to schedule of activities including run the business and project workloads.
Support, lead or guide others in CQV projects.
Requirements Qualifications
Hon. Degree in a Science or Engineering discipline.
Experience in a GMP environment essential.
Experience
Minimum 5 years’ experience in a similar role.
Demonstrated knowledge in pharmaceutical/biopharmaceutical technical manufacturing operations, with experience of successfully delivering technical projects.
Knowledge of Regulations and applicable standards for Quality, Safety, Regulatory.
Skill Set
Demonstrated high level of complex problem solving and attention to detail.
Demonstrated capability of working and collaborating across multiple functional teams.
Demonstrated capability to deliver results RFT, in an FDA/HPRA Regulated production environment.
Stakeholder management of multiple decision makers, corporate colleagues, cross‑functional team by demonstrating the ability to maintain and strengthen trust relationships with people on all levels.
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Industry Pharma/Biotech/Clinical Research
City Cork city
State/Province Cork
Country Ireland
Job Description 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.
The
Specialist, Engineering,MS&T, Q&V
will be an active member within the cross functional team providing support and guidance and will strive for technical excellence to ensure the success of the Q&V team.
Responsibilities
Lead/Execute/Participate in Equipment and System Validation Lifecycle processes, Qualification (IQ/OQ/PQ), Revalidation, Requalification and Equipment Periodic Reviews, for Equipment and Systems.
Coordinate with and guide other departments or outside contractors/vendors to complete validation tasks.
Participate in CSV Validation Lifecycle processes, Qualification (RS/QAP/UAT etc), CSV Periodic Reviews, for Equipment and Systems.
Participate and comply with the Manufacturing Division Quality Management System (QMS) requirements, including ownership, as relevant.
Investigate and troubleshoot problems which occur and determine solutions or recommendations for changes and/or improvements.
Execute/Participate in change controls and other compliance related tasks e.g. non‑conformances.
Support regulatory audits.
Lead/Support Shipping Qualification and/or Cleaning Verification/Validation activities.
Work on own initiative to maintain adherence to schedule of activities including run the business and project workloads.
Support, lead or guide others in CQV projects.
Requirements Qualifications
Hon. Degree in a Science or Engineering discipline.
Experience in a GMP environment essential.
Experience
Minimum 5 years’ experience in a similar role.
Demonstrated knowledge in pharmaceutical/biopharmaceutical technical manufacturing operations, with experience of successfully delivering technical projects.
Knowledge of Regulations and applicable standards for Quality, Safety, Regulatory.
Skill Set
Demonstrated high level of complex problem solving and attention to detail.
Demonstrated capability of working and collaborating across multiple functional teams.
Demonstrated capability to deliver results RFT, in an FDA/HPRA Regulated production environment.
Stakeholder management of multiple decision makers, corporate colleagues, cross‑functional team by demonstrating the ability to maintain and strengthen trust relationships with people on all levels.
#J-18808-Ljbffr