Packaging Engineering Specialist, New Product Commercialization
Organon is a Women’s Health Company that believes in a better and healthier every day for every woman! We are a passionate, global community of thousands dedicated to redefining the future of women’s health. Our mission is to deliver impactful medicines and solutions for a healthier every day. But what really makes it work at Organon is our people.
We’re looking for real, passionate team players, curious innovators, forward thinkers, empowered by the idea of shaping their career, and ready to bring their fire to embrace change and the opportunities it brings for progress.
At Organon, you’ll get to enjoy the best of both worlds: the open, agile, collaborative culture of a start-up, and operating at the scale of a Fortune 500 company with an international footprint that serves people in more than 140 markets.
It’s going to be an exciting future—come be a part of it!
This position is for a Packaging Engineering Specialist to be focused on new package development in the New Products Commercialization organization. Packaging Commercialization is responsible for package design, testing, and specification development of packaging systems included in IND filings through World-Wide commercial product filings and supporting product stabilization after commercial launch. This work will be executed with internal sites and/or external partners/CMOs with oversight from New Product Commercialization.
This position can be 100% remote.
The Packaging Specialist is a key technical point-person who will make informed component selection decisions followed by design testing and process validation activities associated with late-stage pharmaceutical and medical device project portfolio. This role supports the Integrated Development Supply Team (IDST) efforts for creating and executing process development plans, aligning with the clinical supply strategy, developing, and documenting the knowledge base needed for regulatory filings, and supporting the product through early launch and supply. The Packaging Specialist ensures that relationships with relevant partner groups - upstream, downstream, and parallel - are handled collaboratively, efficiently, and effectively.
The successful candidate should have demonstrated pharmaceutical, medical device or Over The Counter (OTC) product packaging selection, specification generation, and protection testing experience related to the primary/secondary/tertiary product packaging. The Specialist will ensure appropriate strategy and document control processes are followed in completion of the project activities.
The Specialist will be expected to build inclusive collaborative partnerships with internal and external stakeholders such as: Packaging Technology Operations, Commercial Marketing, Clinical Supply, internal packaging sites, Contract Manufacturers, Analytical Testing, Quality Assurance, and Regulatory Affairs.
The Specialist will provide direction for selecting new product packaging components followed by establishing component specifications, test methods /validation as needed.
The Specialist will support packaging equipment selection and packaging line layout decisions for new product introductions.
The specialist is expected to demonstrate packaging ownership and make informed cost/ benefit decisions based on analysis of inputs, outcomes, risks, and likely return.
Supports development plans and outcomes for meeting the Target Product Profile and commercial processes across the portfolio.
Escalates issues appropriately for visibility and resolution within IDST structure.
Anticipates and adjusts or redefines goals and plans for the Packaging Working Group supporting the IDST in response to changes in business needs.
Makes informed cost/ benefit decisions based on analysis of inputs, risk and likely return, and takes ownership of the outcomes.
Leverages communication and business processes for technical topics to facilitate decision making and leverage the collective experience of the organization.
Collaborate with key partner groups to help set strategy and tactics across functions.
Applies scientific/technical concepts and techniques in pursuit of resolving scientific/technical issues
Education Minimum Requirements:
Bachelor of Science in Packaging Engineering or a related field with a minimum of three years pharma/med device/OTC packaging experience.
Required Experience and Skills:
Familiarity with current USP, ISO, ASTM, ISTA and quality system regulations for Pharmaceutical and Medical Device Packaging.
Experience with distribution and logistics testing of the product to demonstrate the packaging system meets the protection requirements.
Who We Are:
Organon delivers ingenious health solutions that enable people to live their best lives. We are a $6.5 billion global healthcare company focused on making a world of difference for women, their families and the communities they care for. We have an important portfolio and are growing it by investing in the unmet needs of Women’s Health, expanding access to leading biosimilars and touching lives with a diverse and trusted portfolio of health solutions. Our Vision is clear: A better and healthier every day for every woman.
Subject to applicable law, all prospective US Organon hires will be required to demonstrate that they have been fully vaccinated against COVID-19 with a vaccine authorized or approved by the Food and Drug Administration (FDA), or qualify for a medical or religious accommodation to this vaccination requirement, as a precondition of employment.
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