Overview
PSC Biotech is a leading biotech consultancy firm founded in 1996, headquartered in Pomona, California, and operating globally. We provide cloud‑based software solutions for Quality Management and Regulatory Inspections, as well as services in pharmaceuticals contract manufacturing and metrology.
Responsibilities
Design, author, review, approve and execute qualification/validation documentation and cycle development studies in line with standard approval processes.
Design, author, review, approve and execute development of change controls.
Resolve technical issues encountered during study execution.
Engage with Production, Maintenance and Quality representatives during Cycle Development & Performance Qualification activities.
Provide technical input into quality notifications by authoring, reviewing and approving investigations.
Perform root‑cause analysis of system failures and sub‑standard performance, using standard tools and methods.
Support continuous improvement through Lean Six Sigma methodologies.
Serve as validation representative for cross‑functional projects and represent the validation team at global technical forums.
Drive compliance of global policies, procedures and guidelines, regulatory requirements and current Good Manufacturing Practices (cGMP) in day‑to‑day activities.
Ensure compliance via documentation, risk assessments, corrective action closure, participation in audits and inspections and proactively highlight any compliance issues.
Support regulatory audits and submissions as required.
Work collaboratively to drive a safe and compliant culture in Carlow.
Qualifications
Relevant technical qualification(s) in Applied Pharmaceutical, Biological or Chemical sciences, or a related Technical/Engineering qualification.
Proven track record in delivering excellence in a GMP manufacturing environment.
Knowledge of CTU equipment qualification, thermal mapping equipment and thermal mapping skills.
Experience in exception/deviation management and change control.
Demonstrable experience leading technical projects.
Knowledge of process monitoring systems, automation systems (DeltaV), operational intelligence & data systems (Pi System) within a GMP manufacturing environment.
Evidence of continuous professional development.
Knowledge of regulatory and code requirements to Irish, European and international standards.
Analytical skills to interpret complex data and link to equipment performance and out‑of‑spec findings.
Report, standards, policy writing skills.
Experience in equipment and process validation, sterile fill‑finish processes and equipment.
Proficiency in Microsoft Office and other job‑related computer applications.
Excellent communication, presentation and interpersonal skills.
Preferred Experience
Equipment periodic validation.
Equipment validation lifecycle.
Project management skills/qualification.
Filter validation and container closure validation.
Autoclave/SIP sterilization validation.
Dry heat sterilization.
Isolator qualification.
Vial and syringe processing technologies.
Temperature mapping.
Cleaning validation.
Location
Carlow site, Ireland.
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