Engineer Senior - Calsoft Labs
New Albany, OH 43054
About the Job
Onsite - New Albany 100%
Ideal candidate: Packaging education and experience is a requirement. AutoCAD and illustrator software requirements. 5 YOE in pharmaceutical packaging. Minimum of a bachelors in packaging. Open relocate on their own.
This external worker position reports into the Packaging Engineering group under Combination Product Operations (CPO) and is located in New Albany, OH. The position will support global supply, new product introductions, partnerships/acquisitions and combination products. This position will apply engineering principles to implement the accurate design, qualification and implementation of Primary and Secondary Packaging components and the associated systems such as documentation, equipment, and processes. A knowledge of common materials utilized in healthcare packaging is key to this role. Material knowledge of structural components are integral in the day-to-day oversight of this role: bottles, labels, trays, lidding material, leaflets, paperboard, sterile barrier packaging, corrugate, etc. This role will may 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.
Responsibilities:
" Lead testing and evaluations to recommend and select primary and secondary packaging materials for both large and small molecule products
" Perform distribution testing per ASTM D4169. Complete testing standards using ASTM, ISO, TAPPI, USP and EP
" Writing of test protocols, perform technical evaluations and testing to support reports used to uphold the use of selected materials and packaging components
" Creating specifications along with implementation through technical change records
" Build, modify, and approve engineering drawings using AutoCAD, Adobe Illustrator, Solid Works, or similar software applications
" Assist in troubleshooting and leading investigations on Packaging Component problems for areas in production, warehouse, incoming inspection (minor and major deviation lead)
" Support line trials and packaging validation activities prior to introduction of any new or change in components/processes
" Collaborate with multi-functional teams (i.e. Manufacturing, Process Development, Quality, Supply Chain, Maintenance, Device Engineering, Primary Container Engineering, Artwork/Labeling, Regulatory, etc.) in pre-commercial and commercial activities
Preferred Qualifications:
" Bachelor s degree in Packaging, Materials Science, 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:
" Familiar with distribution testing per ASTM D4169. Familiarity with ASTM, ISO, TAPPI, USP and EP testing standards.
" Knowledge of primary and secondary packaging systems and material science is critical to the position
" Strong organizational, project management, technical problem solving and communication (written and verbal) skills, and the ability to work in teams and adapt to continuously evolving environment
" Excellent understanding of Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP)
" Independent thinker with demonstrated skills working in teams or leading project teams
" Strong interpersonal and communication skills
Ideal candidate: Packaging education and experience is a requirement. AutoCAD and illustrator software requirements. 5 YOE in pharmaceutical packaging. Minimum of a bachelors in packaging. Open relocate on their own.
This external worker position reports into the Packaging Engineering group under Combination Product Operations (CPO) and is located in New Albany, OH. The position will support global supply, new product introductions, partnerships/acquisitions and combination products. This position will apply engineering principles to implement the accurate design, qualification and implementation of Primary and Secondary Packaging components and the associated systems such as documentation, equipment, and processes. A knowledge of common materials utilized in healthcare packaging is key to this role. Material knowledge of structural components are integral in the day-to-day oversight of this role: bottles, labels, trays, lidding material, leaflets, paperboard, sterile barrier packaging, corrugate, etc. This role will may 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.
Responsibilities:
" Lead testing and evaluations to recommend and select primary and secondary packaging materials for both large and small molecule products
" Perform distribution testing per ASTM D4169. Complete testing standards using ASTM, ISO, TAPPI, USP and EP
" Writing of test protocols, perform technical evaluations and testing to support reports used to uphold the use of selected materials and packaging components
" Creating specifications along with implementation through technical change records
" Build, modify, and approve engineering drawings using AutoCAD, Adobe Illustrator, Solid Works, or similar software applications
" Assist in troubleshooting and leading investigations on Packaging Component problems for areas in production, warehouse, incoming inspection (minor and major deviation lead)
" Support line trials and packaging validation activities prior to introduction of any new or change in components/processes
" Collaborate with multi-functional teams (i.e. Manufacturing, Process Development, Quality, Supply Chain, Maintenance, Device Engineering, Primary Container Engineering, Artwork/Labeling, Regulatory, etc.) in pre-commercial and commercial activities
Preferred Qualifications:
" Bachelor s degree in Packaging, Materials Science, 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:
" Familiar with distribution testing per ASTM D4169. Familiarity with ASTM, ISO, TAPPI, USP and EP testing standards.
" Knowledge of primary and secondary packaging systems and material science is critical to the position
" Strong organizational, project management, technical problem solving and communication (written and verbal) skills, and the ability to work in teams and adapt to continuously evolving environment
" Excellent understanding of Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP)
" Independent thinker with demonstrated skills working in teams or leading project teams
" Strong interpersonal and communication skills
Source : Calsoft Labs
