Engineer

Onsite New Albany 100%
Supplier Call notes:
New site (New Albany OH)
New drug product packaging
Packaging engineers / packaging verification testing
Open to other industries (food/ consumer product/cosmetics/home fragrance)
Multiple shifts might be required (1st, 2nd, 3rd) - Shift work possible, predominately M-F 8am-5pm, must be amenable to different shift when needed.

This position reports into the Packaging Engineering group under Combination Product Operations (CPO) in Client Ohio (AOH). The position will support global supply, new product introductions, partnerships/acquisitions and combination products. This position utilizes physics, engineering and chemistry principles coupled with advanced and diverse materials science understanding and principles to assist in the evaluation, design, qualification and implementation of packaging components and the associated systems such as documentation, equipment and processes. A knowledge of common materials utilized in pharmaceutical packaging is key to this role. This role will support Client's manufacturing network by applying broad knowledge of pharmaceutical packaging operations, equipment, devices, and materials to develop the industry's best combination product assembly and packaging processes. Understanding of packaging manufacturing equipment and processes and how materials interact with these is essential to the position. The job will require both planning and technical support of complex projects supporting a new site start-up. This role will be responsible for planning and overseeing projects to ensure on-time completion, establish priorities, report project status updates, and manage project dashboards for the Secondary Packaging Engineering team. This role will have some entry level management potential and the successful candidate will also utilize excellent organizational, project management, technical problem solving and communication (written and verbal) skills, with the ability to work in teams and adapt to a rapidly changing environment. This role requires management, problem solving, communication (written and verbal), and organizational skills, and the ability to work in teams and adapt to rapidly changing environment. Project Management experience supporting implementation of commercial packaging configurations is preferred. Candidate must possess extensive knowledge and expertise in the use of project management methodologies and tools.

This position is responsible and accountable for the following:
Project Management of entry level engineers and contingent workers
Evaluation, recommendation and selection of new secondary packaging materials for pharmaceutical products
Assessing complex problems relating to materials, recommending and implementing solutions
Write test protocols, perform technical evaluations and submitting technical assessment reports to justify the use of selected materials
Write Technical Specifications
Representing Final Product Technologies as required
Technology transfer from clinical to commercial or from site to site for packaging components and equipment processes
Establish priorities to ensure all projects are managed within expected due dates
Lead and present new packaging ideas, concepts and design ideas to the Product Development team
Ensures cGMP and regulatory compliance are met
Ensures that change control procedures are followed working with QA and Regulatory to implement changes
Participants in Pre-Approval Inspections (PAI) and interact with regulatory bodies (e.g., FDA, EMEA, etc.) as needed
Collaborates with cross-functional teams (i.e. Research, QA/QC, Supply Chain, Maintenance, Manufacturing, Regulatory, etc.) in pre-commercial and commercial activities

Basic Qualifications:
Doctorate degree in Packaging Engineering, Materials Science, Mechanical Engineering, Chemical Engineering, or related engineering field
OR
Master's degree in in Packaging Engineering, Materials Science, Mechanical Engineering, Chemical Engineering, or related engineering field & 5 years of Packaging Engineering experience
OR
Bachelor's degree in in Packaging Engineering, Materials Science, Mechanical Engineering, Chemical Engineering, or related engineering field & 8 years of Packaging Engineering experience

Preferred Qualifications:
Master's degree in Packaging Engineering, Materials Science, Pharmacology, Mechanical Engineering, Chemical Engineering, or related engineering field
7+ years of packaging engineering experience with 4+ years within the Pharma/Bio industry

Demonstrated Competencies/Skills:
Leading technical teams
Independent thinker with demonstrated skills working in teams or leading technical project teams
Strong Interpersonal and communication skills
Project management
Ability to manage competing priorities