Process Engineering Manager

West Pharmaceutical Services•Walker, MI

23h

About The Position

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 SummaryReporting 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

Requirements

Bachelor's in Engineering, preferably Plastics
Experience: 5-8 years of experience in an Engineering/production environment, particularly in a plastic injection molding environment.
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
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.
Able to routinely use standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.
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.
Must be able to work scheduled work week, plus overtime and/or irregular hours as required to complete assignments.
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

Nice To Haves

Preferred understanding of EDARTS, RJG Master Molder certificate

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
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.