Senior Manager, Process Validation

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.

About the role

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. You will ensure the qualification and validation of equipment, facilities, utilities, automated systems, processes, and process cleaning procedures are carried out in accordance with GMP and relevant guidelines. This role directs the application of resources to assist global sites in improving manufacturing processes and developing optimal solutions that meet or exceed West and/or customer requirements.

Responsibilities

• Provide technical leadership and direction to a globally dispersed Validation Engineering team, defining strategy, planning, and execution of Validation activities within the Global Technical Operations network.
• Provide strategic leadership for long-term and intermediate goals of 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 best practices.
• Drive innovative and efficient approaches to validation incorporating science and risk-based methodologies.
• Oversee the preparation, review, and approval of Site Validation Master Plans.
• Review and/or approve qualification and/or validation documentation (specifications, protocols, reports, etc.) related to instruments, equipment, facilities, utilities, automated systems, manufacturing processes, and cleaning processes, including FAT, SAT, IQ, OQ, and PQ phases in conjunction with program Quality representation.
• Provide oversight of third-party generated protocols and reports in conjunction with program Quality representation.
• Foster and encourage shared learnings across the organization, e.g., system and technology best practices.
• Chair, schedule, and minute validation meetings and participate in meetings as required.
• Perform periodic reviews of systems to maintain validation status.
• Support the setup and maintenance of electronic validation documentation while ensuring compliant archiving and filing of hard copy validation documentation across all programs.
• Oversee the implementation of site validation strategies to meet customer and West needs.
• Work with all departments to ensure new processes meet their requirements.
• Play a key role in Global Technical Operations transfer programs to ensure flawless transition into Operations.
• Represent West at customer meetings to ensure business needs are met.
• Assist with the training and development of personnel at all levels on new processes or systems introduced to the company.
• Ensure procedures and systems are in place to facilitate the introduction of new processes and equipment.
• Lead and manage a high-performing team to deliver defined business goals and objectives.
• Perform additional duties at the request of the direct supervisor.

Requirements

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

Skills

• In-depth/working knowledge of ISO 13485, EU GMP, and CFR Part 820.
• Excellent understanding of plastic process manufacturing, computer validation, analytical methods and testing, and documentation systems.
• Experience dealing with customers in previous employment.
• Excellent written and verbal communication skills, with the ability to accurately document work performed.
• Demonstrated ability to lead, influence, and train others.
• Ability to work in a fast-paced environment and travel as required by the position (up to 5%, or 13 business days per year).
• Strong organizational and prioritization skills; detail-oriented and self-motivated.
• Ability to collaborate across functional teams and work effectively in a matrixed team environment.
• Ability to work independently on projects while collaborating with all departments.
• Previous people management experience required.
• Support and contribute to Lean Sigma programs and activities toward delivery of set targets.
• Compliance with the company’s safety and quality policies at all times.

Pay

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 applicable plans.