Senior Packaging Validation Engineer

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Senior Executive – US TAG at ACL (Pharmaceuticals, Life Sciences and Medical Devices)

Job Title : Senior Validation Engineer

Location : New Albany OH

Duration : 12 Months

Location Options : AOH. 100% Site Presence Required.

The position is expected to travel for approximately 10%.

Top 3 Must Have Skill Sets :

knowledge of packaging equipment

protocol generation and execution

OUTPUTS

Key responsibilities will include supporting the packaging C&Q activities of the Amgen product portfolio to AOH. Additional responsibilities will include the provision of technical operations support for the continuous improvement of device assembly and packaging line capacity and performance, and advisory of technical improvement projects. The Sr. Validation Engineer must ensure effective communication throughout the Amgen Ohio commercial site and Amgen network with all stakeholders and deliver on technical deliverables.

RELATIONSHIPS

The Senior Validation Engineering is expected to build on the Amgen network expertise across the Amgen commercial and clinical operations for product assembly, label and packaging. The position is expected to leverage this network in support of GMP technical expertise, performance trending, equipment standardization and troubleshooting / process improvements at AOH.

JOB SPECIFICATIONS

The successful candidate will have :

Knowledge of high-speed, highly automated secondary packaging operations

Knowledge of the validation of equipment such as PFS assembly, cartoners, vision systems

Experience in writing protocols

Experience in executing protocols

Capable of executing multiple projects

Communication skills and ability to work with other people

Bring innovative solutions for continuous process improvement

Experience with Kneat

Experience with MiniTab is a plus

Basic Qualifications

Doctorate degree OR Masters degree and 2 years of experience OR Bachelors degree and 4 years of experience OR Associates degree and 8 years of experience OR High school diploma / GED and 10 years of experience

Seniority level

Seniority level

Mid-Senior level

Employment type

Employment type

Contract

Job function

Industries

Pharmaceutical Manufacturing and Biotechnology Research

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