About PSC Biotech
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 a unique selling point, which includes the opportunity to work with a talented cohort of like‑minded professionals operating in the pharma/biotech industry. We offer a permanent contract of employment giving exposure to working in top pharmaceutical client sites in a diverse‑cultural setting.
Employee Value Proposition
Employees are the “heartbeat” of PSC Biotech; we provide unparalleled career development through in‑house training, mentorship, and constant guidance to facilitate career progression. We believe in creating high‑performing teams that exceed client expectations, deliver scalable business unit deliverables, stay under budget, and meet timelines.
Our Carlow site is excited to offer a fantastic Engineering Specialist (Validation) opportunity for candidates interested in a new challenge in a cGMP regulatory environment. Successful candidates will support several aspects of validation, requiring experienced, energetic, and committed engineers in sterilisation – Autoclaves and SIP of vessels.
Responsibilities
Design, author, review, approve, and execute qualification/validation documentation and cycle development studies in line with the standard approval process.
Design, author, review, approve, and execute development and execution of change controls.
Resolve technical issues encountered during study execution.
Engage with production, maintenance, and quality representatives during execution of 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 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 forums.
Drive compliance with global policies, procedures, guidelines, regulatory requirements, and current cGMP in day‑to‑day activities, ensuring consideration of GMP impact and decision‑making.
Accountable for compliance via documentation completion, risk assessments, closing out corrective actions, participation in audits and inspections, and proactively highlighting any compliance issues.
Support regulatory audits and submissions as required.
Work collaboratively to drive a safe and compliant culture in Carlow.
Requirements
May be required to perform other duties as assigned.
What skills you will need
Relevant technical qualification(s) in applied pharmaceutical, biological, or chemical sciences, or an applied technical/engineering qualification; proven track record in delivering excellence.
Knowledge of CTU equipment qualification.
Knowledge of thermal mapping equipment.
Thermal mapping skills.
Exception/deviation management and change control.
Demonstrable experience leading technical related projects.
Knowledge of process monitoring systems, automation systems (DeltaV), operational intelligence, and data systems (Pi System) within a GMP manufacturing environment would be beneficial and desirable.
Evidence 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, linking to equipment performance and out‑of‑spec findings as appropriate.
Report, standards, policy writing skills.
Equipment and process validation.
Sterile fill‑finish processes and equipment.
Proficiency in Microsoft Office and job‑related computer applications.
Excellent communication, presentation, and interpersonal skills to interface effectively with all levels of colleagues and external customers in a team‑orientated manner.
Knowledge and experience of the below areas will be considered advantageous
Equipment periodic validation
Equipment validation lifecycle
Project management skills/qualification
Filter validation and container closure validation
Autoclave/SIP sterilisation validation
Dry heat sterilisation
Isolator qualification
Vial and syringe processing technologies
Temperature mapping
Cleaning validation
The successful candidate will be required to work both independently and in a cross‑functional team to accomplish validation project objectives. Work with moderate direction and demonstrate skill and knowledge at the position level.
Relevant technical qualification(s) in applied pharmaceutical, biological, or chemical sciences, or an applied technical/engineering qualification; proven track record in delivering excellence.
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