What are the responsibilities and job description for the Senior Packaging Validation Engineer position at ACL Digital?
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:
packaging validation experience
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
Competencies/Skills:
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
