Title:  Validation Technician (Automation)

Working at West means having an opportunity to work by the side of our patients and customers, our global team members and the communities in which we operate – which all help contribute to a Healthier World.

At West, we are by the side of patients. The work we do impacts patients’ lives each and every day – our products are a critical part of healthcare delivery and we are proud of the role we play to improve patient health. We work by the side of our team members. We come together as one global team to deliver for our customers and help them address their challenges. We are a diverse, close-knit community of professionals, where everyone has a voice and opportunity to learn and grow through mutual trust and respect. With a 95 year plus history, we have a track record for success, which includes reported sales of $2.14B in 2020. We serve by the side of our community. Giving back is in our DNA—our team members across more than 50 sites globally are involved with hundreds of charities that have special meaning to them through our West Without Borders team member-led giving program.

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.

Basic Qualifications: 

•    Third level qualification preferred, in Engineering/Quality/Science.

Preferred Knowledge, Skills and Abilities:
•    Third level qualification preferred, in Engineering/Quality/Science.
•    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.