Validation Engineer Specialist-Shift
1 week ago
Job Description About PSC Biotech Who are we?
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 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 candidates will support several aspects of Validation.
The roles available that will require experienced, energetic and committed engineers are in the following areas: Sterilisation – Autoclaves, SIP of vessels Cleaning – Parts Washer and CIP of vessels Isolator (Filling, Sterility & Material Transfer isolators) - HVAC, VHP, E-Beam and Depyrogenation systems Controlled Temperature Units (CTU) – Temperature/Humidity Mapping Filter Validation Container Closure Integrity Validation Shift Pattern: Candidates must be flexible to be available to work shifts as may be required (2 Cycle 5 days a week: 7am-3pm and 3pm-11pm) Requirements Role Functions: 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.
May be required to perform other duties as assigned.
Experience, Knowledge & Skills: 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.
Demonstratable 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 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.
Works with moderate work direction and is skilled and knowledgeable to the position.
Qualifications & Education: Relevant Degree level, 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.
#LI-AP1 Requirements Relevant Degree level, 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 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
-
Validation Engineer Specialist-Shift
1 week ago
Carlow, Ireland Psc Biotech Ltd Full timeAbout PSC Biotech Who are we?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...
-
Validation Engineer Specialist-Shift
2 weeks ago
Carlow, Ireland PSC Biotech Ltd Full timeAbout PSC Biotech Who are we?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...
-
Validation Engineer Specialist-Shift
2 weeks ago
The Municipal District of Carlow, Ireland PSC Biotech Corporation Full timeAbout PSC BiotechWho are we?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...
-
Validation Engineering Specialist
7 days ago
Carlow, Ireland Psc Biotech Ltd Full timePSC Biotech Ltd offers a unique opportunity for engineering specialists looking to take their careers to the next level. As a Validation Engineer, you will play a crucial role in ensuring compliance and efficiency in our cGMP regulatory environment.Job Description:The successful candidate will support various aspects of validation, including design,...
-
Biotech Validation Specialist
7 days ago
Carlow, Ireland Psc Biotech Ltd Full timeAbout the RoleThis is an exciting opportunity for experienced engineers to join PSC Biotech Ltd as a Validation Engineer. The successful candidate will support various aspects of validation, including Sterilisation, Cleaning, Isolator, Controlled Temperature Units, and Filter Validation.The role requires flexibility to work shifts as may be required....
-
Engineering Validation Specialist
6 days ago
Carlow, Ireland Recruitment By Aphex Group Full timeRecruitment By Aphex Group is currently seeking an experienced Engineering Validation Specialist to join our team. This role will provide support for the development, implementation, and maintenance of validation protocols and procedures across various areas.About the Role:Design and execute qualification/validation documentation and cycle development...
-
Validation Engineer
1 day ago
Carlow, Ireland Claran Consultants Ltd Full timeRole Description We are excited to offer a fantastic Engineering Specialist (Validation) opportunity for candidates interested in a new challenge in a cGMP regulatory environment. The successful candidates will support several aspects of Validation. The roles available that will require experienced, energetic and committed engineers are in the following...
-
Validation Engineer
2 weeks ago
Carlow, Ireland Recruitment by Aphex Group Full timeThese are 11-month contracts with a view to extension. Purpose Our 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 candidates will support several aspects of Validation. The roles available that will require experienced,...
-
Validation Engineer
7 days ago
Carlow, Ireland Recruitment By Aphex Group Full timeThese are 11-month contracts with a view to extension.Purpose Our 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 candidates will support several aspects of Validation.The roles available that will require experienced,...
-
Validation Engineer
5 days ago
Carlow, Ireland Asset Recruitment Full timeref.01250Validation Engineer Asset Recruitment is recruiting a Validation Engineer for a 12-Month contract role, with a high likelihood for extension, on behalf of our client, a growing pharmaceutical manufacturer in Carlow.Role As part of a significant expansion project, the successful candidate will join their science, engineering/ manufacturing &...
-
Validation Engineernew
6 days ago
Carlow, Ireland Next Generation Full timeAre you an experienced Validation Engineer looking for your next challenge?We are currently hiring an Engineering Specialist (Validation) to join a leading biopharmaceutical company at their state-of-the-art Carlow site.This is a fantastic opportunity to work in a dynamic and fast-paced cGMP regulatory environment, supporting critical validation activities...
-
Validation Engineer
23 hours ago
Carlow Town, Co. Carlow, Ireland Claran Consultants Ltd Full timeRole Description We are excited to offer a fantastic Engineering Specialist (Validation) opportunity for candidates interested in a new challenge in a cGMP regulatory environment. The successful candidates will support several aspects of Validation. The roles available that will require experienced, energetic and committed engineers are in the following...
-
Validation Engineer
4 weeks ago
Carlow, Ireland PSC Biotech Ltd Full timeJob DescriptionAbout 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...
-
Validation Engineer
2 weeks ago
Carlow Town, Co. Carlow, Ireland Recruitment by Aphex Group Full timeThese are 11-month contracts with a view to extension. Purpose Our 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 candidates will support several aspects of Validation. The roles available that will require experienced,...
-
Validation Engineer
4 weeks ago
Carlow, Ireland Recruitment by Aphex Group Full timeThis is a 12-month contract with a view to extension. Purpose The role will require the leadership of an experienced, energetic, and committed Senior/ Lead Engineering (CQV/ Technical Engineer) with broad experience in Vial and Syringe Filling operations and the below key areas. Vial and Syringe Sterile operations Isolators, VHP, decontamination systems....
-
Engineering Validation Specialist
5 days ago
Carlow, Ireland Next Generation Full timeCompany OverviewAs a leading biopharmaceutical company, we are committed to delivering innovative solutions that transform lives. Our state-of-the-art Carlow site is at the forefront of this mission, and we are seeking an experienced Validation Engineer to join our team.
-
Validation Engineer
16 hours ago
Carlow, Ireland Life Science Recruitment Ltd Full time11 month contract Validation Engineer On site Carlow AMC22979 We are currently hiring for a Validation Engineer role with a rapidly expanding biopharmaceutical manufacturer based in Carlow. In this role you will support various areas of validation on site including Sterilization, cleaning, isolators, CTU, filter and Container closure validation The ideal...
-
Validation Specialist
7 days ago
Carlow, Ireland Life Science Consultants (LSC) Full timeAt Life Science Consultants (LSC), we have an exciting contract opportunity for a skilled professional to join our team as a Validation Engineer. This is a chance to work with a global Biopharmaceutical company in Carlow, Ireland.The role involves designing, authoring, reviewing, and approving qualification/validation documentation and cycle development...
-
Senior Validation Engineer
3 weeks ago
Carlow, Ireland PE Global Full timePE Global is recruiting for a Senior Validation Engineer on behalf of our pharmaceutical client in County Carlow. This is an initial 12-month contract, hybrid role. Our Carlow site is excited to offer a fantasticSeniorEngineering Specialist (Validation)opportunity for candidates interested in a new challenge in a cGMP regulatory environment. The successful...
-
Validation Engineer
3 weeks ago
Carlow, Ireland Recruitment by Aphex Group Full timeThis is an 11-month contract and is a hybrid position, About the Role: We are seeking a highly skilledValidation Engineer to join our team in a cGMP regulatory environment. This is an exciting opportunity for an experienced professional to take on a challenging role, focusing onCleaning Validation, includingRecovery/Cleanability studies, and driving...
