Manufacturing Engineer

Overview:

Tekwissen group, is a workforce management provider throughout the USA and many other countries in the world. This client is a German multinational Pharmaceutical and biotechnology company and one of the largest pharmaceutical companies in the world, headquartered in Leverkusen, and areas of business include pharmaceuticals; consumer healthcare products, agricultural chemicals, seeds and biotechnology products.

Job Title: Manufacturing Engineer

Location: Indianola PA 15051

Duration: 12 Months

Job Type: Contract

Work Type: Onsite

Description:

Education:

Bachelor’s degree required in engineering discipline

Department

The Medical Device External Manufacturing department resides within the client Pharmaceuticals Product Supply organization responsible for overseeing client’s external contract manufacturers.

Primary responsibilities:

The primary responsibility include manufacturing engineering activities, project support and small-scale project management with client’s external contract Mmanufacturing 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

TekWissen Group is an equal opportunity/affirmative action Employer (m/f/d/v) supporting workforce diversity.

TekWissen

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