Validation Engineer (CTU)

About PSC Biotech

Who we are?
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.

Overview:

Our clients Carlow 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 candidate will support several aspects of Validation: predominantly qualification of Controlled Temperature Units (CTU).

Responsibilities:

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 forums

Drive 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 compliance

Supporting regulatory audits and submissions as required.

Work collaboratively to drive a safe and compliant culture in Carlow.

May be required to perform other duties as assigned.

Requirements

Experience, Knowledge and Skills:

The 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 qualification

Knowledge of thermal mapping equipment

Thermal mapping skills

Exception / Deviation Management and Change Control.

Demonstrable 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 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, 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 required

Excellent 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 Validation

Equipment Validation Lifecycle

Project Management Skills/Qualification

Filter Validation & Container Closure Validation

Autoclave/SIP Sterilisation Validation

Dry Heat Sterilisation

Isolator Qualification

Vial and Syringe Processing Technologies

The 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:

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.