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Sr Packaging Development Engineer
5200 Corporate Parkway Wilson, NC 27893 US
Job Description
POSITION SUMMARY:
Responsible for putting into operation and service advanced and complex principles of packaging technology and engineering involving the independent initiation, execution and implementation of technical packaging designs for drug products on large scope projects requiring minimal direction and supervision. Works cooperatively with the department Supervisor/Manager to establish and coordinate project priorities and upon occasions supervises other packaging engineering activities for special projects. Applies acquired packaging technology skills to manage projects to a successful conclusion in regard to cost, schedule and performance, applying the most appropriate technology and packaging concepts, to meet and/or exceed company objectives.
PRINCIPAL ACTIVITIES:
- Represents the Packaging Development department on new product development teams, prepares CMC documentation for NDA and ANDA product submissions, and reviews documents from other engineers prior to submission to Regulatory Affairs. Displays a cooperative attitude with a strong desire for the new product team's success. Exhibits ability to work hard and smart, and make decisions with timely responses to assignments.
- Assists and supports department Supervisor/Manager in establishing project priorities by functioning as a minimally supervised project manager and team leader for high profile Packaging Development projects which have an impact on corporate manufacturing, marketing, sales, and company profits. Prepares in advance and establishes a course of action for assigned projects that is efficient and achieves results. Recognizes priorities, sets daily goals and uses effective means for self and project management.
- Accepts responsibility for managing own performance. Actively develops and applies new project management skills compatible with the changing packaging technology environment. Maintains performance level in stressful situations and time lines. Independently develops, creates, and implements packaging material specifications (MCSs), BOMs, CNs, packaging descriptions, and bar code assignments which communicate product packaging requirements to company production support departments, providing the basis for the purchasing and planning of packaging materials to sustain plant manufacturing operations.
- Efficiently coordinates, communicates, and provides essential Packaging Development project information, activities, and technical assistance to Product Development, Marketing, Manufacturing, Materials Management, Quality Assurance, and Purchasing departments. Works effectively with personnel in all departments during periods of rapid and humid change, deal with technical problems and multi-task between one project and another without conflict. Shows ability to function well under pressure, assess and to cope with frustration or conflict without breaking down when faced with time commitment pressures.
- Makes obvious a clear desire to meet expectations and accomplish goals of assigned packaging projects in a timely and cooperative manner with department colleagues.
- Initiates and performs departmental cost reduction studies to contain package material cost or effect package changes that result in higher production line speeds, greater efficiency, less waste, and reduction in labor requirements. Expresses desire to make high quality decisions based on sound cost analysis and review of facts and alternatives.
- Sees opportunities and works proactively and closely with the Packaging Development Supervisor/Manager to avoid problems and assure that all packaging designs and materials currently used, and proposed future packaging, meets all legal, technical, and FDA requirements. Communication with Regulatory Affairs to provide necessary information, data, or specifications is an essential new product responsibility.
- Additional projects and tasks as assigned.
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REQUIREMENTS
- Bachelor’s degree in engineering (Packaging or mechanical engineering preferred).
- 5-10 years engineering experience, including experience with FDA regulations, medical, drug and device products.
- Understanding and familiarity in pharmaceutical or medical diagnostic industry.
- Certified Packaging Engineer desirable but not required.
- Proficient in pharmaceutical and combination product container closure systems including the following: vial/stopper/seal, SVP and LVP prefilled bags, prefilled syringes.
- Technical packaging technology knowledge relating to materials, equipment, design, and material specification writing.
- Excellent technical writing and verbal communication skills. Experience negotiating.
- Computer expertise in application programs such as word processing, spreadsheets, relational databases, project management, power point.
- Good judgment and decision skills.
- Problem solving and multi-tasking.
- Project supervision and project management skills.
- Ability to adapt and handle change.
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
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