Principal Process Validation Engineer

Overview

At West, we’re a dedicated team 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 committed to creating a healthier environment and planet through our sustainability efforts.

This position is a hybrid role (3 days onsite)

In this role, you will be responsible for contributing to the development and implementation of the validation engineering strategy while 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.

• 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 learnings across the organization 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 setup 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.

• 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.

• 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

• Minimum 8 years of validation engineer experience in a cGMP regulated industry, and experience of working in a high-volume…