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
Reporting to the Senior Automation Engineer, this role will support Automation projects with key focus around customer specification, Validation Master Plan, protocols, and reports. This person will provide the company with the technical and Validation resource to manage the Validation deliverables on selected Automation projects and will coordinate the necessary activities for ensuring the timely closure of Validation activities on projects.
Essential Duties and Responsibilities
- Support Automation and Validation Engineers with validation activities.
- Will be required to assist in preparing IQ, OQ and PQ protocols and reports.
- Raising change control requests.
- Drafting change control proposals.
- Drafting project trackers.
- Aligning the required approvers.
- Managing customer approval.
- Writing validation technical reports.
- Chairing meetings and taking minutes.
- Co-ordinating project timelines across all automated lines.
- Aligning all the required resources for completion of a validation project.
Education
Third level qualification, in Engineering/Quality/Science. Candidates with exceptional and relevant work experience may also be considered in lieu of degree qualifications. NFQ Qualification guidelines
Preferred Knowledge, Skills and Abilities
- Good understanding and knowledge of validations in a Medical Device environment.
- Good understanding of computer system validation.
- Must have a thorough understanding of statistics, SPC, and ideally the use of Minitab.
- Must have excellent communication skills both oral and written.
- Auditing experience to the requirements of ISO 13485 / 21 CFR Part 820 is preferred.
- Must be able to prioritize and organise tasks.
- Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description
- Able to comply with the company’s safety policy at all times
- Able to comply with the company’s quality policy at all times.
West is an equal opportunity employer and we value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, or disability status. If you have a special need that requires accommodation in order to apply to West, please send an email to Apply.Accommodation@westpharma.com. Where permitted by law, an offer of employment with West Pharmaceutical Services, or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of background screening and/or a pre-employment drug screening.