Validation Specialist

6 months ago

Dublin, Ireland West Pharmaceutical Services Full time

Who We Are:

At West, we’re a dedicated team that is connected by a purpose to improve patient lives that has been at the center of our Company for more than a century. Our story began when Herman O. West solved the problem of supplying penicillin in mass quantities to the US Government during World War 2. Through our work to deliver thousands of life-saving and life-enhancing injectable medicines to millions of patients daily, West’s indelible mark on the healthcare industry has just begun. A name started our story. How will yours help write our future?

There’s no better place to join an inclusive community of professionals with opportunities for lifelong learning, growth and development. Supported by benefit programs, we empower the physical, mental, emotional and financial health of our team members and their families.

We believe in giving back to help those in need in the communities where we live and work. And are equally committed to creating a healthier environment and planet through our sustainability efforts.

Job Summary :

This role reports to the Senior Automation Engineer. The role-holder will act as the Commissioning, Qualification and Validation (CQV) Subject Matter Expert (SME) supporting Engineering and Operations projects. The role will support projects through the project lifecycle from determination of user requirements through to approval of PQ and subsequent revalidation(s).

Essential Duties and Responsibilities:

Generation and approval of CQV procedures and documentation templates. Performance and documentation of a Validation Impact Assessment (VIA) for each project. Generation and approval of Commissioning, Qualification and Validation Master Plans (CMP, QMP, VMP) as appropriate for each project. Provision of CQV input into the definition, documentation, and approval of User (Customer) Requirements. Preparation, review, and approval of CQV documentation, such as user requirements and other specifications, risk assessments, requirements traceability matrices, protocols, and reports, through all phases of the project including DQ, FAT, SAT, IQ, OQ and PQ, working in conjunction with West/Customer program Quality representation. Management, control, and approval of the use of vendor documentation, such as Test Plans, to support system test phases in compliance with the West QMS. Leadership of and participation in test phases and activities including DQ, walk-downs, FAT, Commissioning/SAT, IQ, OQ and PQ. Generation, maintenance, and approval of a Requirements Traceability Matrix (RTM) for each validated system. Leadership of risk assessment processes, such as System/Component Level Impact Assessment (CLIA/SLIA) and Quality Risk Assessments (QRA). Participation in equipment process and/or Design (P)FMEAs. Review and approval of third party generated documentation, such as FDS, HDS, SDS and test plans, in conjunction with West/Customer program Quality representation. Generation and management of change requests and associated actions on MasterControl. Generation and management of non-conformances and associated actions on MasterControl. Generating and management of a CQV document tracker. Archiving and filing of CQV documentation associated with the project, including hard-copy and management of soft-copy archival on MasterControl. Leading the review and disposition of all attribute and variable data against customer specification / drawing e.g., Analysing and reporting of key measures eg. Ppk's, Cpk's, FOT/FAT visual inspections. Provision of CQV support and expertise to the resolution of customer issues. Prepare data/presentations and attend review meetings with the customer. Implement best practices principles into West QMS as applicable. Support internal and supplier audits. Trending and tracking of Validation data to drive improvements e.g., sampling data, number of non-conformances, project protocols and reports. Act in accordance with the company’s Guiding Principles and adherence to the corporate Code of Conduct. Compliance with all local site Environmental, Health and Safety regulations Compliance with all local site company policies, procedures, and corporate policies. Perform additional duties at the request of the direct supervisor.

Basic Qualifications: 

Third level qualification, in Engineering/Quality/Science. Candidates with exceptional and relevant work experience may also be considered in lieu of degree qualifications.

Preferred Knowledge, Skills, and Abilities:

Must have a third level degree qualification in an Engineering, Quality or Science discipline. Must have a minimum of 3 years’ post graduate experience in a CQV role in a GMP-regulated high-volume manufacturing environment (i.e., within the Medical Device/Pharmaceutical sector). Must have an in-depth knowledge of CQV practice in a GMP-regulated environment. Must have a good working knowledge and understanding of Computer Systems Validation (CSV) as an integral part of the CQV process. Must have a thorough working knowledge of quality systems such as ISO 13485 / 21 CFR Part 820. Must have a thorough understanding of statistics and Statistical Process Control (SPC) and ideally have a good working knowledge of Minitab. Must have excellent oral and written communication skills. Must be a self-starter, capable of acting on own initiative and working independently and being able to prioritize and organise tasks. A good working knowledge and understanding of plastic component manufacturing and assembly is desirable. Auditing experience to the requirements of ISO 13485 / 21 CFR Part 820 is desirable.

Travel Requirements:

No travel requirements with this role

Physical & Mental Requirements:

Physical

Sedentary - exerting up to 10lbs/4kgs of force occasionally, and/or negligible amount of force frequently or constantly to life, carry, push, pull, or otherwise move objects, including the human body. Job-related activities that require physical activity:  Being able to stand or walk to use communal office equipment (Scanner/Printer etc...)

Mental

Good team worker as well as ability to work independently. Applies appropriate judgment to resolve routine situations. Writes clear, concise, and neat information. Foresight and planning abilities to multitask and manage competing priorities.

#LI-DJ1

West embraces diversity and equality of opportunity. We foster an environment where all individuals are safe, treated fairly, valued and respected. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, disability status or other applicable legally protected characteristics. Where permitted by law, employment with West Pharmaceutical Services, Inc. or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of post-offer background screening and/or drug screening.

  • Manager, Engineering Commissioning, Qualification

    1 month ago

    Dublin, Ireland Bristol Myers Squibb Irl Full time

    Working with Us Challenging. Meaningful. Life-changing. Those arent words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the...

  • Structural Engineer

    4 weeks ago

    Dublin, Ireland Construction Specialist Recruitment Full time

    Our client are a leading engineering firm specializing in innovative structural design solutions. Dedicated to delivering high-quality projects that meet the needs of our clients while ensuring safety and sustainability. They are currently seeking a talented Structural Design Engineer to join their dynamic team. Job Responsibilities: - Develop and design...

  • Specialist QA

    4 months ago

    Dublin, Ireland Amgen Full time

    The Quality Assurance (QA) Specialist is a senior and active role within the broader QA function. QA specialists will be required to understand and grasp a broad range of quality related competencies. The QA Specialist will report to the PQA Packaging & Complaints Senior Manager and will be required to be a Subject Matter Expert in their assigned area of...

  • Technical Services Specialist

    4 weeks ago

    Dublin, Ireland Recruitment by Aphex Group Full time

    Purpose The Technical Services Specialist has primary responsibility in supporting the cGMP manufacture of biological bulk drug substance (BDS). The Technical Specialist will provide processing expertise to support routine commercial manufacturing, technology transfer, and process validation for Downstream manufacturing of new/existing drug substance (DS)...

  • Accounts Receivable Specialist

    2 weeks ago

    Dublin, Ireland Celtic Careers Full time

    Dublin 15 / West Dublin Location Salary circa 35-36k Full Time Permanent Office based role. Job Specification: Our client based in Dublin 15 are looking to recruit a full-time Accounts Receivable Specialist. Working closely with the Group Financial Controller & Finance team this is a broad hands-on role where your experience and value add skills should make...

  • Quality Specialist

    2 months ago

    Dublin, Ireland PSC Biotech Ltd Full time

    Job DescriptionAbout 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...

  • Privacy Specialist- Danish Market

    2 weeks ago

    Dublin, Ireland Cross Border Talents Full time

    We are looking for a dedicated Privacy Specialist to join our client's team supporting the Danish market. In this role, you will work with one of the worlds leading technology companies, helping to enforce their privacy policies. You will evaluate privacy requests under European Law, ensuring compliance with policies and standards. If you thrive in a...

  • Packaging Engineering Specialist

    5 months ago

    Dublin, Ireland TEAM HORIZON Remote Work Freelance Full time

    Description Packaging Engineering Specialist Team Horizon is seeking a Packaging Engineering Specialist (initial 12-month contract) for our client who are a global leader in the biopharmaceutical industry, for their site in Dublin. The successful candidate will be responsible for providing technical and/or engineering support for Finished Product (FP)...

  • QA Specialist, Compliance

    3 months ago

    Dublin, Ireland West Pharmaceutical Services Full time

    Job Summary : In this role the Quality Specialist, Compliance is responsible for maintaining the ongoing compliance of the Quality Management System. Quality Specialist, Compliance is responsible for the administration of the Document Management system on site including coordination of all document change request activities for their nominated area of...

  • Finance EHR Corporate Services Specialist

    2 weeks ago

    Dublin, Ireland Mater Private Hospital Group Full time

    The Electronic Health Record (EHR) Corporate Services Specialist (Finance) is responsible for ensuring that the Meditech EHR system effectively supports and integrates with the hospital groups financial operations. This role serves as the primary point of expertise for financial aspects of EHR implementation, including billing, revenue cycle management, cost...

  • Operations Specialist

    2 weeks ago

    Dublin, Ireland Navro Full time

    We are looking for an Operations Specialist to join our fast-growing FinTech! We're looking for an enthusiastic and driven Operations Specialist  to join our dynamic and growing team. At Navro, we value diversity and are committed to creating an environment where everyone feels supported and empowered to contribute their unique perspectives. Who we are...

  • Quality Specialist

    2 months ago

    Dublin, Ireland PSC Biotech Ltd Full time

    About 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...

  • HR Specialist

    4 months ago

    Dublin, Ireland AIG Full time

    Payroll Specialist and HR AdministratorWho we areAmerican International Group, Inc. (AIG) is a leading global insurance organization. Building on 100 years of experience, today AIG member companies provide a wide range of property casualty insurance, life insurance, retirement solutions, and other financial services to customers in more than 80 countries and...

  • Warehouse Specialist

    3 weeks ago

    Dublin, Ireland Catalyx Full time

    Join Our Team as a Distribution Specialist in Dublin Catalyx is looking for a dedicated Distribution Specialist to manage warehousing activities at our customer site in Dublin on an initial 12-month contract. You will be responsible for tasks including goods receipt, sampling, materials handling, picking, shipping, and inventory management within our...

  • Technical Specialist

    3 weeks ago

    Dublin, Ireland Kuok (Singapore) Limited Full time

    This position is for K2 Data Centres, a company under Kuok (Singapore) Limited, based in Dublin, Ireland.Purpose of the Role: To provide specialist, training and service support of an operational Critical environment providing 24/7/365 on-site support of a production data center facility. The Technical Specialist is responsible for the emergency response,...

  • Process Engineer

    3 weeks ago

    Dublin, Ireland Pale Blue Dot® Recruitment Full time

    Our client,  a leader in developing, qualifying, and commercializing innovative drug delivery systems and biomedical products based in Dublin,  are looking for a Process Engineer ( Injection Moulding Specialist) to join the team. As a Process Engineer specializing in Injection Molding, you will play a key role in developing, optimizing, and scaling...

  • Data Annotation Specialist

    1 week ago

    Dublin, Ireland Welocalize Full time

    OVERVIEW We are seeking a QA Analyst - Data Annotation Specialist to contribute to a high-profile technology project. The ideal candidate will have a foundational understanding of quality assurance, data annotation, and data handling. Additionally, they must be fully proficient in English (UK) and possess excellent communication skills. They will...

  • Senior Quality Specialist

    4 months ago

    Dublin, Ireland Endo Operations Limited Full time

    Description The Senior Quality Specialist, Quality Operations leads an individual system and assists in managing the Quality System functions for cGxP manufacturing and distribution activities from local and Third Party manufacturing facilities. Provides quality guidance on product transfers and validations and will ensure that all activities related...

  • Private Client Data Conversion Specialist

    3 months ago

    Dublin, Ireland US012 Marsh & McLennan Agency LLC Full time

    Description: Our not-so-secret sauce. Award-winning, inclusive, Top Workplace culture doesn’t happen overnight. It’s a result of hard work by extraordinary people. More than 10,000 of the industry’s brightest talent drive our efforts to deliver purposeful work and meaningful impact every day. Learn more about what makes us different and how...

  • Patient Service Specialist Float

    3 months ago

    Dublin, Ireland Florida Cancer Specialists Full time

    At Florida Cancer Specialists & Research Institute, we believe our people are our strength and we invest in them. In addition to having a positive impact on the people and communities we serve, associates benefit from significant professional opportunities, career advancement, training and competitive wages.A LITTLE BIT ABOUT FCS Since 1984, Florida Cancer...