Validation Engineer

4 months ago

Dublin, Ireland West Pharmaceutical Services Full time

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.

POSITION SUMMARY:

Provide continuity for the validation program for assigned plant or functional area by writing, reviewing and approving validation documentation. Other duties may be assigned

ACCOUNTABILITIES:

Responsible for assuring compliance to West Pharmaceutical Systems validation program. Ensure that the validation requirements are documented to provide direction for meeting the validation needs of the customers, regulatory bodies, manufacturing plants, research & development, IT and laboratory groups. Provide guidance to system/process stakeholders for validation documents, as to content and format of validation life cycle documentation. Write protocols and reports directly related to QA, e.g. (statistical sampling plans, assessment criteria (Validation Rationale), compliance, guidelines, specifications, etc.). Review and approve validation life cycle documentation, including change control documents, specifications, protocols, deviations, and reports. Provide guidance during protocol incident process, including reporting, investigations and approval of resolutions. Utilize engineering, vendor, and customer specifications to generate and execute testing protocols for equipment following West and customer procedures and good documentation practices. Strong attention to detail and knowledge of pharmaceutical processes and protocol around automation processes, equipment, and systems. Keep current with the industry standard practices and FDA requirements for validation. Write/revise validation templates and validation plans. Meet agreed to project deadlines

BASIC QUALIFICATIONS:

Education: Minimum Bachelor of Science Degree in Engineering or Science.

Experience: Minimum 3-5 years of experience writing, approving and executing validation protocols and reports, specifically in the following areas: Process Validation, Sterilization, Equipment/Utility Qualification and Computer System Validation. Ability to comprehend computer systems applications and business/manufacturing processes. Excellent written and verbal communication skills, good problem solving skills, and ability to function as a team member and leader.

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