1 Bayer Drive Indianola, PA 15051 US
Target Pay Rate: 30-44.65/hr **salary will be commensurate with experience
Department: The Medical Device External Manufacturing department resides within the client Pharmaceuticals Product Supply organization responsible for overseeing external contract manufacturers.
The primary responsibility include manufacturing engineering activities, project support and small-scale project management with client's external contract M\manufacturing organizations (CMO). CMO support is typically focused on product quality, sustaining activities, and continuous improvement. The incumbent will work with New Product Development engineering, Global Quality, Regulatory, and other internal stakeholders. The position will also support process improvement initiatives and cost savings programs.
Position Duties and Responsibilities:
- Support performance of technical tasks related to manufacturing, packaging/labels, and process validations of sterile disposable products manufactured at Contract Manufacturers (CMOs).
- Review and approve validation protocols and reports.
- Support sustaining activities through implementation of process and product changes (e.g. creation of material masters, qualification of new sources of raw materials, manufacturing technologies, process changes, etc).
- Provide technical support for continuous improvement through cost savings programs to deliver quantifiable cost savings.
- Effectively communicate internal requirements to CMOs and potential constraints of CMOs to internal stakeholders. Communicates technical product matters to a broad and diverse audience.
- Support the execution activities to resolve product issues/deviations to ensure continuity of supply
- Define and coordinate product testing, and document and communicate results/rationale for material disposition.
- Draft and/or review protocols and associated test reports
Skill & Competency Requirements:
- Ability to generate and/or execute test methods and protocols
- Strong customer focus, both internal and external customers
- Good written and oral communication as well as strong presentation skills
- Understanding basic engineering tools and technologies
- Basic understanding of Lean manufacturing principles
- Independently demonstrate the ability to create ideas and solutions
- Attention to detail, goal seeker, and demonstrated [strong] work ethic
- Proficient with Microsoft Office tools especially MS Word, Excel, Visio, and PowerPoint
Preferences: (list nice-to-haves such a specific knowledge items, certifications, skills, abilities, etc.)
- The preferred candidate will have experience working in a highly regulated environment
- The preferred candidate should have some level of experience with contract manufacturers (Process validations, technology transfers, etc).
- The preferred candidate will have knowledge medical disposables manufacturing and/or medical disposables design and development
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