What are the responsibilities and job description for the Packaging Manager (Laboratory, Regulatory, Medical/Pharma) position at Tekcogno?
Manager Packaging Laboratory
Covington, GA
Full-Time/Direct-Hire
The Opportunity:
This position is responsible for providing leadership, strategy and follow-through in the design, development, testing, coordination, and implementation of packaging technology and systems for Bards products. The position is responsible for interfacing and/or interacting with management and appropriate project teams to evaluate packaging design and implement efficient changes, meeting internal and external customer needs through timely management and response from the R&D Packaging Lab, communications, as well as facts and data that have a direct impact on budget, headcount, resource and capacity utilization and project timelines. The manager will work directly with R&D Packaging Engineering and packaging suppliers while staying abreast of current trends, development activities, and potential new packaging platforms. The position and function are responsible for package design and material qualification, closure integrity and adherence to ISO, FDA and other domestic and international regulations pertaining to packaging systems. Development and implementation of Standard Operating Procedures for design development, material selection, and design control are further requirements. Lead, develop and train staff for Bard/BD and ISO procedure compliance are essential. Packaging support is provided to Bard/BDs manufacturing facilities. This position and in alignment with the global regulatory function/department is an active team member on international industry and regulatory committees as it relates to packaging.
QUALIFICATIONS
To perform this job successful, an individual must be able to perform each crucial duty satisfactorily. The requirements listed in this section and below are representative of the knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Experience with packaging stability studies and packaging performance testing preferred.
- Understanding of sophisticated applied statistics as relates to packaging processes.
- Excellent communication skills (verbal, written, and presentation).
- ISTA CPLP professional certification, IOPP CPP certification, and/or ASTM D10 or F02 committee preferred.
- Understanding of GMP, ISO 11607 and 13485, FDA, ISTA, ASTM and other regulatory issues relating to medical device packaging.
EDUCATION and/or EXPERIENCE
- B.S. Degree in Engineering field required. Advanced degree preferred.
- 3 - 5 years direct experience working in regulated or healthcare field.
- Package design and materials selection, through criteria evaluation, validation, and implementation preferred.
- Packaging Testing Lab and supervisory experience preferred.
- Understanding of GMP, ISO 11607 and 13485, FDA, ISTA, ASTM and other regulatory issues relating to medical device packaging.
COMPUTER SKILLS
- Proficient with SharePoint and MS Office including PowerPoint, Outlook, Project, Excel and Word.
- Able to comprehend and use computer-controlled laboratory equipment.
- TOP/CAPE, CAD and Solidworks preferred
Job Type: Full-time
Pay: $120,000.00 - $140,000.00 per year
Work Location: In person
Salary : $120,000 - $140,000
