Senior Manager, Process Validation

West Pharmaceutical Services; Greenfield (IN); On-site; USD 117,000 - 150,000; Full time

Job summary

West Pharmaceutical Services seeks an experienced Validation Engineer to lead the development and execution of validation strategies for Global Technical Operations. You will ensure qualification of equipment, facilities, utilities, automated systems, and processes in line with GMP and industry standards.

Reporting to the Director of Global Validation and Metrology Services, you will drive risk-based validation, mentor teams, and harmonize standards across sites while managing site validation

Qualifications

• Must have a third level qualification, at a minimum to degree level, in Computer Science, Engineering or related fields.
• Must have 10 years of validation engineer experience in a cGMP regulated industry.
• Must have a minimum of 10 years post graduate experience of working in a high-volume manufacturing environment ideally in the Medical Device / Pharmaceutical sector.

Responsibilities

• Provide technical leadership and direction to a globally dispersed Validation Engineering team with responsibility for defining strategy, planning and execution of Validation activities within the Global Technical Operations network.
• Provide strategic leadership of long-term and intermediate goals the Global Technical Operations Network.
• Direct resources from functional responsibility for Validation in support of programs within the Global Technical Operations Network.
• Participate in the harmonization and implementation of Validation standards and procedures across the Global Technical Operations network based on current regulations, industry standards and industry practices.
• Drive innovative and efficient approaches to validation incorporating science and risk-based approach.
• Oversee the preparation, review, and approval of Site Validation Master Plans.
• 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.
• Oversight 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.
• Perform periodic reviews of systems in order to maintain validation status.

Skills

ISO 13485

EU GMP

CFR Part 820

Plastic process manufacturing

Computer validation

Analytical methods

Documentation systems

Education

Bachelor's degree in Computer Science, Engineering or related fields

Job description

Description

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?

Description

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.

Job Summary

Reporting to the Director of Global Validation and Metrology Services, this role is responsible for contributing to the development and implementation of the validation engineering strategy for West Global Technical Operations 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. This role will direct the application of resources within and across its functional responsibility to assist global sites in improving the manufacturing of products and develop the most optimum processes and solutions which meet or exceed West and/or customer requirements.

Essential Duties And Responsibilities

• Provide technical leadership and direction to a globally dispersed Validation Engineering team with responsibility for defining strategy, planning and execution of Validation activities within the Global Technical Operations network.
• Provide strategic leadership of long-term and intermediate goals the Global Technical Operations Network.
• Direct resources from functional responsibility for Validation in support of programs within the Global Technical Operations Network.
• Participate in the harmonization and implementation of Validation standards and procedures across the Global Technical Operations network based on current regulations, industry standards and industry practices.
• Drive innovative and efficient approaches to validation incorporating science and risk-based approach.
• Oversee the preparation, review, and approval of Site Validation Master Plans.
• 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.
• Oversight 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.
• 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 programs is compliant with site policies.
• Oversee the implementation of site validation strategies to meet customer and West needs.
• Work with all departments across the business to ensure that new processes meet their requirements.
• Play a key part in Global Technical Operations transfer programs to ensure flawless transition into Operations.
• 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 & objectives.
• Perform additional duties at the request of the direct supervisor.

Education

• Must have a third level qualification, at a minimum to degree level, in Computer Science, Engineering or related fields.

Work Experience

• Must have 10 years of validation engineer experience in a cGMP regulated industry.
• Must have a minimum of 10 years post graduate experience of working in a high-volume manufacturing environment ideally in the Medical Device / Pharmaceutical sector.

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.
• Previous people management experience required.
• 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

5%: Up to 13 business days per year

Pay Transparency

The annual base salary range for this position is €100,900.00 - €130,200.00. Total target compensation is determined using objective and gender-neutral criteria, including relevant experience, qualifications, skills, market benchmarks, geographic location, and the scope and responsibilities of the role.

This position may be eligible for variable compensation and other incentive programs in accordance with the terms of the applicable plans within the country of employment. In addition, team members are eligible to participate in the company’s benefits and total rewards programs applicable to their location and employment status.

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 [e-mail] . 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.