Industry: Pharma/Biotech/Clinical ResearchExperience: 4-5 yearsLocation: Carlow, Ireland
Job Description
PSC Biotech is a leading biotech consultancy offering cloud-based software solutions for quality management, regulatory inspections, and metrology services.
The Carlow site is seeking an Engineering Specialist (Validation) to work in a cGMP regulatory environment. The successful candidate will support various aspects of validation, focusing on sterilization equipment such as autoclaves and SIP of vessels.
Responsibilities
Design, author, review, approve, and execute qualification and validation documentation and cycle development studies.
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 and performance qualification activities.
Provide technical input into quality notifications by authoring, reviewing, and approving investigations.
Perform root‑cause analysis of system failures and substandard 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 with global policies, procedures, guidelines, regulatory requirements and cGMP in all day‑to‑day activities.
Ensure compliance through documentation completion, risk assessments, corrective action closure, audit and inspection participation, and proactive issue highlighting.
Support regulatory audits and submissions as required.
Work collaboratively to drive a safe and compliant culture in Carlow.
May perform other duties as assigned.
Requirements
Desired skills and qualifications:
Relevant technical qualification(s) in applied pharmaceutical, biological or chemical sciences, or applied technical/engineering.
Proven record of delivering excellence in a GMP manufacturing environment.
Knowledge of CTU equipment qualification, thermal mapping equipment, and mapping skills.
Experience in exception/deviation management and change control.
Demonstrated experience leading technical projects.
Knowledge of process monitoring systems, automation systems (e.g., DeltaV), and operational intelligence data systems (PiSystem) in a GMP setting.
Continuous professional development evidence.
Knowledge of Irish, European, and international regulatory codes, standards, and practices.
Ability to analyse and interpret complex data, linking to equipment performance and out‑of‑spec findings.
Report, standards, and policy writing skills.
Experience in equipment and process validation, including sterile fill‑finish processes and equipment.
Proficiency in Microsoft Office and related job‑related applications.
Excellent communication, presentation, and interpersonal skills to interface effectively with all levels.
Knowledge of equipment periodic validation, validation lifecycle, and vial and syringe processing technologies is advantageous.
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