Packaging Engineer - Drug Product / Secondary Packaging & Verification

Packaging Engineer – Drug Product / Secondary Packaging & Verification3 Key Consulting is hiring a Packaging Engineer – Drug Product / Secondary Packaging & Verification for a consulting engagement with our direct client, a leading global biopharmaceutical company.Job Description:This role supports new drug product packaging initiatives, with a focus on packaging engineering and packaging verification testing.

Candidates with relevant experience in industries such as food, consumer products, cosmetics, or home fragrance are also encouraged to apply.

The position may require flexibility across multiple shifts (1st, 2nd, or 3rd), though it will predominantly operate Monday through Friday, 8:00 AM to 5:00 PM.

Candidates must be open to adjusting their schedule as needed to support business demands.This position reports into the Packaging Engineering group under Combination Product Operations (CPO) at our client's New Albany, OH.

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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 our 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.Why is the Position Open?Unplanned ProjectTop Must Have Skills:Excellent technical communicationAbility to manage multiple prioritiesExcel in high pressure fast paced environment and professionalDay to Day Responsibilities:Project Management of entry level engineers and contingent workersEvaluation, recommendation and selection of new secondary packaging materials for pharmaceutical productsAssessing complex problems relating to materials, recommending and implementing solutionsWrite test protocols, perform technical evaluations and submitting technical assessment reports to justify the use of selected materialsWrite Technical SpecificationsRepresenting Final Product Technologies as requiredTechnology transfer from clinical to commercial or from site to site for packaging components and equipment processesEstablish priorities to ensure all projects are managed within expected due datesLead and present new packaging ideas, concepts and design ideas to the Product Development teamEnsures cGMP and regulatory compliance are metEnsures that change control procedures are followed working with QA and Regulatory to implement changesParticipants in Pre-Approval Inspections (PAI) and interact with regulatory bodies (e.g., FDA, EMEA, etc.) as neededCollaborates with cross-functional teams (i.e.

Research, QA/QC, Supply Chain, Maintenance, Manufacturing, Regulatory, etc.) in pre-commercial and commercial activitiesBasic Qualifications:Doctorate degree in Packaging Engineering, Materials Science, Mechanical Engineering, Chemical Engineering, or related engineering field, ORMaster's degree in in Packaging Engineering, Materials Science, Mechanical Engineering, Chemical Engineering, or related engineering field & 5 years of Packaging Engineering experience, ORBachelor's degree in in Packaging Engineering, Materials Science, Mechanical Engineering, Chemical Engineering, or related engineering field & 8 years of Packaging Engineering experiencePreferred Qualifications:Master's degree in Packaging Engineering, Materials Science, Pharmacology, Mechanical Engineering, Chemical Engineering, or related engineering field7+ years of packaging engineering experience with 4+ years within the Pharma/Bio industryLeading technical teamsIndependent thinker with demonstrated skills working in teams or leading technical project teamsStrong Interpersonal and communication skillsProject managementAbility to manage competing prioritiesRed Flags:Lack of strong communication skillsLack of ability to learn new systems (SAP, PLM, Smartsheet, etc.)Lack of flexibilityInterview process:Virtual Interviews:1:1 with Sr ManagerGroup Interview with Team Members