Validation Engineer
Company: West Pharmaceutical Services
Location: Scottsdale
Posted on: March 16, 2023
Job Description:
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:
In this role, you will support new product introduction (NPI)
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 Global Engineering projects and
will coordinate the necessary activities for ensuring the timely
closure of Validation activities on projects.
Essential Duties and Responsibilities:
- Preparation, review and or approval of qualification and/or
validation documentation (specifications, protocols, reports etc.)
in relation to instrument, equipment, facilities, utilities,
automated systems, manufacturing processes and cleaning processes
including FAT, SAT, IQ, OQ, PQ phases in conjunction with program
Quality representation.
- Generation of project Validation Master Plans.
- Review of third party generated protocols and reports in
conjunction with program Quality representation.
- Generation of validation documentation (protocols & reports)
against the signed off VMP and customer requirements.
- Generating, communicating and updating Validation document
tracker.
- Ensure the archiving and filing of validation documentation
associated with the project, including the management of same on
MasterControl.
- Participate in equipment process and / or Design FMEAs.
- Participate in the review and disposition of all attribute and
variable data for the program against customer specification /
drawing e.g. Analysing and reporting of key measures eg. Ppk's,
Cpk's, FOT/FAT visual inspections.
- Drive solutions, in conjunction with the appropriate
department, to ensure customer related problems/issues are
communicated and corrective actions are in place and closed in a
timely manner.
- 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
eg Sampling data, project protocols and reports.
- Act in accordance with the company's Guiding Principles and
adherence to the corporate Code of Conduct.
- Compliance to all local site Environmental, Health and Safety
regulations
- Compliance to all local site company policies, procedures and
corporate policies.
- Perform additional duties at the request of the direct
supervisor. Basic Qualifications:
- Must have a third level qualification, at a minimum to degree
level, and/or a Bachelor's degree in Engineering, Quality, or
Science
- Must have a minimum of 3 years post graduate experience working
in a high-volume manufacturing environment
- A thorough working knowledge of quality systems such as ISO
13485 / 21 CFR Part 820 is essential.
- Must have an in-depth knowledge of validations in a Medical
Device environment. Preferred Knowledge, Skills and Abilities:
- An excellent understanding of plastic process manufacturing.
- Good understanding of computer system validation.
- Must have a thorough understanding of statistics, SPC, and
ideally the use of Minitab.
- Auditing experience to the requirements of ISO 13485 / 21 CFR
Part 820 is preferred.
- Able to be aware of all relevant SOPs as per Company policy as
they are related to the position covered by this Job
Description.
- Support and contribute in Lean Sigma programs and activities
towards delivery of the set target.
- Able to comply with the company's safety policy at all
times.
- Able to comply with the company's quality policy at all times.
Travel Requirements:
- Must be able to travel up to 5% of the time. Physical & Mental
Requirements:
- Demonstrated ability to influence and train others.
- Must be able to work in a fast-paced environment.
- Must be able to organize and prioritize tasks; must be detail
orientated and self-motivated.
- Must have excellent communication skills both oral and
written.
- Must be able to prioritize and organize tasks appropriately.
Competencies/Authorities
- Non-US only where required for certain levels
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.
Keywords: West Pharmaceutical Services, Scottsdale , Validation Engineer, Engineering , Scottsdale, Arizona
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