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.
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JOB SUMMARY
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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.
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Essential Duties and Responsibilities
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Responsible for the Process validation of all new or upgraded manufacturing equipment
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Provides 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.
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Provides direction on strategic vision as well as long-term and intermediate goals the Global Technical Operations Network.
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Provides technical engineering expertise and guidance when needed to ensure optimization of manufacturing equipment and processes
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Participates 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.
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Drives innovative, continuous improvement and efficient approaches to validation incorporating science and risk-based approach.
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Leads and fosters an environment of continuous improvement and providing leadership in this area by identifying and implementing lean, efficiency, cost reduction, quality, and service level improvements
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Oversees the preparation, review, and approval of Site Validation Master Plans.
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Implements lean processes, KPI metric analysis and best practice strategies to drive best practices throughout manufacturing operations
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Reviews and/or approves 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.
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Directs, leads and develops the team . Manage the teams’ performance, conduct performance reviews, recruit team, training and development and address any issues that arise in a timely manner
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Oversees third party generated protocols and reports in conjunction with program Quality representation.
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Works collaboratively with internal stakeholders, and/or external vendors in the development/modification of all processes.
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Performs other duties as assigned based on business need
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Education
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Education Level
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Education Details
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Required/
Preferred
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Master's Degree
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In Engineering or technical degree
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Required
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Work Experience
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Experience
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Experience Details
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Required/
Preferred
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Minimum 10 years (Sr Mgr)
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10 years of Process / technical work experience
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Required
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Preferred Knowledge, Skills and Abilities
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KSAs
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Lean Six Sigma training
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cGMP knowledge
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Ability to manage projects from conception to production
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Effectively use software tools to manage timelines and budgets
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Self-motivated and solution-oriented personality.
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Excellent communication and interpersonal skills.
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Good organizational skills.
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Effective problem-solving skills.
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Ability/courage to successfully communicate with any required parties.
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Able to comply with the company’s safety policy at all times
• Compliance to all local environmental, health & safety regulations.
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Able to comply with the company’s quality policy at all times.
• Compliance to all local site company policies, procedures & corporate policies
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Financial Analysis and Reporting experience
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5+ years of practical Process/ Ops related implementation experience in a manufacturing / production environment.
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Travel Requirements
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Estimated Amount
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10%: Up to 26 business days per year
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Physical Requirements
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Job Demand Classification
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Details
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Sedentary
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exerting up to 10lbs/4kgs of force occasionally, and/or negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally, and all other sedentary criteria are met.
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The job description reflects the general details considered necessary to describe the principal functions of the job identified and shall not necessarily be construed as a detailed description of all the work requirements that may be inherent in the job. West Pharmaceutical Services is an Equal Opportunity Employer.
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West embraces diversity and equality of opportunity. We foster an environment where all individuals are safe, treated fairly, valued and respected. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, disability status or other applicable legally protected characteristics. Where permitted by law, employment with West Pharmaceutical Services, Inc. or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of post-offer background screening and/or drug screening.