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.

This position is a hybrid role (3 days onsite)

Job Summary

In this role, you will be responsible for contributing to the development and implementation of the validation engineering strategy whilst ensuring the qualification and validation of equipment, facilities, utilities, automated systems, processes and process cleaning procedures are carried out in accordance to GMP and relevant guidelines.

Essential Duties and Responsibilities

Lead the validation effort for all Strategic Projects on site.
Lead the preparation, review, and approval of the Site Validation Master Plan.
Develop Validation Plans to support Site Validation Master Plan.
Site subject matter expert on Cleaning Validation, Process Validation, Equipment Validation, Computer System Validation, Data Integrity and Facility Qualification.
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.
Review and approval of third party generated protocols and reports in conjunction with program Quality representation.
Fosters and encourages shared learning’s across the organisation e.g. system and technology best practices.
Chair, schedule and minute validation meetings and participate in meetings when required.
Preparation, review, and approval of standard operating procedures and policies.
Perform periodic reviews of systems in order to maintain validation status.
Support the set-up and maintenance of electronic validation documentation while ensuring the archiving and
filing of hard copy validation documentation across all projects.
Develop and implement site validation strategy to meet customer and West needs.
Work with all departments across the business to ensure that new processes meet their requirements.
Represent West at customer meetings to ensure that the needs of the business are met.
Assist with the training and development of personnel at all levels of West on new processes or systems introduced to the company.
Ensure that the procedures and systems are in place to facilitate the introduction of new processes and equipment.
Lead and manage a high performing team to deliver the defined business goals and objectives.
Other duties as assigned.

Additional Responsibilities

He/She is authorized to make a decision to stop work in the plant in accordance with official procedure of West Pharmaceutical services, in cases of huge material damages and/or employees being in jeopardy, especially in absence of Production manager.
He/She is authorized to approve entrance of third parties into the plant, in accordance with official procedure of West Pharmaceutical services.

Education

Bachelor's Degree Must have a third level qualification, at a minimum to degree level, in Computer Science, Engineering or related fields or equivalent experience required

Work Experience

Minimum 8 years of validation engineer experience in a cGMP regulated industry, and experience of working in a high-volume manufacturing environment ideally in the Medical Device / Pharmaceutical sector. required

Preferred Knowledge, Skills and Abilities

Must have in-depth / working knowledge of: ISO 13485; EU GMP, CFR Part 820.
An excellent understanding of plastic process manufacturing, computer validation, analytical methods and testing and documentation systems is desired.
Must have dealt with customers in a previous employment.
Must have excellent written and verbal communication skills as well as the ability to accurately document work performed.
Demonstrated ability to lead, influence and train others.
Must be able to work in a fast paced environment.
Must be able to travel as required by the position.
Must be able to organize and prioritize tasks; must be detail orientated and self-motivated.
An ability to collaborate across functional teams and work effectively in a matrixed team environment.
Must be able to work independently on own projects while working concurrently with all departments.
Support and contribute in Lean Sigma programs and activities towards delivery of the set target
Able to comply with the company’s safety and quality policies at all times

Travel Requirements

5%: Up to 13 business days per year

Physical Requirements

Sedentary-Exerting up to 10lbs/4kgs of force occasionally, and/or negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects, including the human body. Sedentary work involves sitting most of the time.

Additional Requirements

Able to routinely use standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines. Position operates in a professional office environment. May stand or sit for extended periods of time
Must be able to communicate effectively with written and oral skills, make quick decisions, interpret data, read and write, speak in front of groups, express and exchange ideas, understand direction and adhere to procedures
Read and interpret data, information and documents
Must maintain the ability to work well with others in a variety of situations
Must be able to multi-task, work under time constraints, problem solve, and prioritize
Ability to make independent and sound judgments
Observe and interpret situations, analyze and solve problems

#LI-TH1

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.

Principal Process Validation Engineer

Benefits

Job Description