Industry Pharma/Biotech/Clinical Research
Work Experience 4-5 years
City Carlow
State/Province Carlow
Country Ireland
Job Description
About PSC Biotech
PSC Biotech is a leading Biotech Consultancy firm founded in ****, 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.
Who are we?
PSC Biotech disrupts the conventional consultancy model by aligning our Enterprise Value Proposition with unique selling points which include 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.
Take your Career to a new Level
PSC Biotech offers 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 through Learning & Development, in-house training, mentorship, and 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 are being met.
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.
The successful candidate will support several aspects of validation.
The roles available will require experienced, energetic and committed engineers in Sterilisation – Autoclaves, SIP of vessels.
Bring energy, knowledge, innovation to carry out the following:
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 of change controls.
Resolve technical issues encountered during study execution.
Engage with Production, Maintenance and Quality representatives in the assigned area of operations during execution of Cycle Development & Performance Qualification activities.
Provide technical input into quality notification 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 SixSigma 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 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.
Support 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
What skills you will need:
In order to excel in this role, you will most likely have considerable experience in a comparable role, with experience operating as an individual contributor adding value to the business in a GMP manufacturing setting, as well as the following qualifications and skills.
Relevant technical qualifications in Applied Pharmaceutical, Biological, or Chemical sciences or applied Technical/Engineering qualifications; 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 in leading technical related projects.
Knowledge of process monitoring systems, automation systems (DeltaV), operational intelligence & data systems (PiSystem) 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-oriented manner.
Knowledge and experience of the following areas will be considered advantageous:
Equipment Periodic Validation.
Equipment Validation Lifecycle.
Vial and Syringe Processing Technologies.
The successful candidate will be required to work both independently and across-functional teams to accomplish validation project objectives, with moderate work direction and with the skills and knowledge required for the position.
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