Title:  Director of Tooling

Working at West means having an opportunity to work by the side of our patients and customers, our global team members and the communities in which we operate – which all help contribute to a Healthier World.

At West, we are by the side of patients. The work we do impacts patients’ lives each and every day – our products are a critical part of healthcare delivery and we are proud of the role we play to improve patient health. We work by the side of our team members. We come together as one global team to deliver for our customers and help them address their challenges. We are a diverse, close-knit community of professionals, where everyone has a voice and opportunity to learn and grow through mutual trust and respect. With a 95 year plus history, we have a track record for success, which includes reported sales of $2.14B in 2020. We serve by the side of our community. Giving back is in our DNA—our team members across more than 50 sites globally are involved with hundreds of charities that have special meaning to them through our West Without Borders team member-led giving program.

Job Summary:

This role can be based in Dublin, Ireland or near a major West site in the US. Reporting to the Senior Director of Device Manufacturing, Global Engineering, this role is primarily responsible for establishing and leading the global development and implementation of the Tooling Engineering strategy within Global Engineering whilst ensuring the commissioning, qualification and validation of Tooling and Process related equipment, processes and procedures are carried out in accordance to GMP and relevant guidelines. This role will have direct and functional responsibility for Tooling Engineering within the newly established Global Device Manufacturing Engineering function and will be responsible for supporting the execution of various engineering projects relating to medical device manufacturing within West. This role will lead the harmonization of tooling principles, practices and procedures across Device Engineering. 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 Tooling Engineering team with responsibility for defining strategy, planning and execution of Tooling and Process activities within the global Device Manufacturing network. 
• Provide strategic leadership of long-term and intermediate goals within Device Manufacturing and Technology in collaboration with the Global Engineering/Operations Network. 
• Supports the development and execution of the strategic plan to achieve short- and long-term business objectives.  
• Supports operations in establishing the technology and equipment requirements needed to deliver against the customer needs and facility operational goals and objectives. 
• Direct resources from functional responsibility for Tooling Engineering in support of Device programs within CM and Proprietary Device manufacturing. 
• Lead the harmonization and implementation of Tooling Engineering standards and procedures across the Device Manufacturing Network based on current regulations, industry standards and industry practices. 
• Drive innovative and efficient approaches to asset validation incorporating science and risk-based approach. 
• Review and approve cGMP documents including, but not limited to, validation master plans, protocols, and reports. 
• Provide Tooling expertise for assessment of changes, deviations, CAPAs and audit findings. 
• Support CM Sales team in all new business quoting and gathering customer requirements relating to Tooling Engineering requirements. 
• Serve as primary technical contact on strategic or politically sensitive issues. 
• Lead, mentor, and develop a project team or direct reports.  
• Understands CM manufacturing facilities’ needs, goals, and objectives and identifies technology solutions to support them. 
• Identify, execute, and implement transactional process improvement initiatives with regards to the commercialization of products. 
• Build strong cross functional working relationships with stakeholders to ensure high quality deliverables meeting cGMP and West procedural requirements. 
• 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. 
• Other duties as assigned. 

Basic Qualifications: 

• Bachelor’s degree in a technical discipline to include Engineering/Quality/Science.  
• Minimum of 10 years’ experience in a regulated manufacturing environment. 
• Must have in-depth / working knowledge of: ISO 13485; EU GMP, CFR Part 820. 
• Relevant experience in a cGMP regulated industry. 
• An excellent understanding of prototype and production tooling, plastic process manufacturing, analytical methods and testing and documentation systems is desired. 
• Previous people management experience with demonstrated ability to lead, influence and train others. 

Preferred Knowledge, Skills and Abilities:

• Must have excellent written and verbal communication skills as well as the ability to accurately document work performed. 
• Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description  
• 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:

• Must be able to travel up to 20% of the time

Physical and Mental Requirements:

• Sedentary - exerting up to 10lbs/4kgs of force occasionally, and/or negligible amount of force frequently or constantly to life, carry, push, pull, or otherwise move objects, including the human body.  Sedentary work involves sitting most of the time. 
• Must be able to work in a fast-paced environment. 
• Must be able to organize and prioritize tasks; 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. 
• Must be able to multi-task, work under time constraints, problem solve, and prioritize.  
• Must also be able to maintain confidentiality and resolve conflicts.  
• Ability to make independent and sound judgments. 

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 and/or a pre-employment drug screening.