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Process Engineering Manager
Process Engineering ManagerWest Pharmaceutical Services • Tempe, AZ, US
Process Engineering Manager

Process Engineering Manager

West Pharmaceutical Services • Tempe, AZ, US
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Process Engineering Manager

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 Sr. Global Process Engineering Manager, this role is primarily responsible for supporting the Global Processing Injection Molding group by evaluating and implementing new equipment through the commissioning, validation and involvement of process improvement projects across all CM sites. This role will support the harmonization of process / tooling principles, practices, and procedures across Global Process / Tooling Engineering group. Through understanding of Injection Molding / process interactions and development of process, provide all pertinent validations of both tooling and process. Interacts with site Engineering / Customers on new projects or issues pertaining to the Injection Molding processes.

Essential Duties and Responsibilities

  • Provide leadership defining the strategy in support of long-term and intermediate goals within Global Process Engineering in collaboration within the Global Contract Manufacturing and Technology Network.
  • Develop scope of work, plan and manage for Injection Molding / Equipment Validation projects for the introduction of all new products into the company and compiling standard specifications for each process and monitoring all existing production to standard specifications.
  • Use strong analytical skills to understand and implement customer / user needs, market requirements and other design inputs.
  • Support CM Sales team in all new business quoting and gathering customer requirements relating to Process Engineering requirements.
  • Identify, execute, and implement process improvement initiatives across the Global platform.
  • Provide leadership / guidance on the installation and validation of new equipment / process development through SAT / IQ / OQ / PQ.
  • Ensure that the procedures and systems are in place to facilitate the introduction of new processes and equipment.
  • Drive idea creation, development, bread boarding / prototyping, feasibility testing, etc. to evaluate viability of ideas.
  • Lead and advise component material selection with a strong emphasis on polymer selection for injection molded parts.
  • Hands-on engineering, such as reverse engineering, simple assembly and machining work, component testing and failure analysis
  • Provide continuity for the validation program for assigned plant or functional area by preparing technical documentation / presentations. Provide project leadership for materials / process related projects by coordinating the efforts of the various departmental disciplines for the successful completion according to plan and budget
  • Managing internal and external resources to meet the technical requirements of the project, such as outside vendors, and management of techs and / or interns
  • Work with Tooling Design team to plan innovative technical approaches to design solutions
  • Coordinate engineering meetings with manufacturing plants. Identify, monitor status of results or projects.
  • Leveraging internal and external resources to solving complex problems
  • Help execute specific strategies, tactics and action plans for the location, as part of the overall Delivery Systems / Innovation product development plan, inclusive of management / tracking of project activities and resources

Additional Responsibilities

  • 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.
  • Education

  • Bachelor's in Engineering, preferably Plastics
  • Work Experience

  • Experience : 5-8 years of experience in an Engineering / production environment, particularly in a plastic injection molding environment.
  • Preferred Knowledge, Skills and Abilities

  • Regulatory compliance in cGMP manufacturing and testing of Pharmaceutical or Medical Device Products.
  • Ability to manage projects, teams, maintain timelines, and execute projects in a Global Engineering environment
  • Expertise in injection molding techniques, methodology, and trouble-shooting methods; a deep understanding of equipment, process, and tools relating to injection molding
  • Must have excellent written and verbal communication skills as well as the ability to accurately document work performed.
  • Experience working with teams and influencing decisions
  • Must have an in-depth knowledge of Statistical Process Control (SPC) and Design of experiments (DOE) and demonstrate use of same.
  • Excellent understand of the Scientific approach to Injection Molding
  • Preferred understanding of EDARTS, RJG Master Molder certificate
  • Must have knowledge in computer systems; integrated manufacturing systems; word processing and spreadsheets
  • Support and contribute to Lean Sigma programs and activities towards delivery of the set target
  • Must be able to organize and prioritize tasks; must be detail orientated and self-motivated.
  • Must be able to deal with all levels of employees and work across various departments.
  • Experience in writing and executing validation protocols and reports,
  • Ability to function as a team member.
  • License and Certifications

    Travel Requirements

    10% : Up to 26 business days per year

    Physical Requirements

    Sedentary-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.

    Additional Requirements

  • Able to routinely use standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines. Position operates in a professional office environment. May stand or sit for extended periods of time
  • Must be able to communicate effectively with written and oral skills, make quick decisions, interpret data, read and write, speak in front of groups, express and exchange ideas, understand direction and adhere to procedures
  • Read and interpret data, information and documents
  • Must maintain the ability to work well with others in a variety of situations
  • Must be able to multi-task, work under time constraints, problem solve, and prioritize
  • Ability to make independent and sound judgments
  • Observe and interpret situations, analyze and solve problems
  • Medical Device manufacturing requires strict adherence to standards. Working environment is a manufacturing facility, which houses plastic injection molding machines. Must tolerate fumes and particulate generated from various plastics. Work areas are equipped with adequate lighting, cooling / heating and equipment that are in a good working condition. Must work constructively in an environment that may be stressful due to competing resources while at all times maintaining company confidentiality.
  • Must be able to work scheduled work week, plus overtime and / or irregular hours as required to complete assignments. May stand or sit for extended periods of time. Must transport oneself to and from other areas of the facility and travel to other divisions when necessary. Must have good visual acuity. If specifically necessitated by customer requirements, must be able to see with or without corrective lenses and distinguish color differences for product and safety issues
  • What We Offer

    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.

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