Packaging Engineer – Career Consulting – Raritan, NJ, USA
- Responsible for the maintenance of the accuracy of information in project planning & reporting tools.
- Develops process road mapping exercises, feasibility assessments, cost analysis, timeline estimation, and risk identification.
- Identifies and works with key internal and external stakeholders to identify “Voice of the Customer (VoC)” for secondary packaging needs. This encompasses, but is not limited to collecting information from multiple organizations within the Enterprise such as Customer Value Service, Operations, Quality Assurance, Compliance, Contract Manufacturers, and Clinical.
- Translates VoC into actionable requirements that serve as inputs to the Project Plan.
- Through the use of effective communication, project planning, process excellence, six sigma, and lean methodologies identifies best industry practices within and outside the organization to design an optimal “Playbook Process for Development of Secondary Packaging”.
- Provides input on packaging equipment qualification and process validation strategies (IQ/OQ/PQ/PV).
- Supports and/or develops the required set of documents (Policies, SOP(s), Work Instructions) required to implement the new “Playbook Process for Development of Secondary Packaging”.
- Develops training plans and trains to implement the “Playbook Process for Development of Secondary Packaging”.
- Coordinates packaging activities related to new product launches in accordance with new procedures and in collaboration with the site departments that are responsible for business launches and international launch management, quality, supply chain and affiliates.
- Pilots new process with projects representative of the population of stakeholders or products that will be required to use the new process, for example:
- Solids, liquids, topicals, biologicals
- Cold Chain
- Contract Manufacturers (Tech Transfers)
- Combination Products
- Medical Devices (?)
- Smart Packaging
- Ability to take complex data and simplify into a workable cohesive solution.
- Leadership presence and follow through.
- Organizational skills in project management (PMP Certification strongly desired).
- Build and maintain strong relationships with all stakeholders.
- Develop a trusted advisor relationship with key customer stakeholders and executive sponsors.
- Accountability to ensure the timely and successful delivery of solutions according to customer needs and stated objective deliverables.
- Strong communication skills both in receptive and expressive as well as written forms of communication.
- Strategic vision to forecast and track key project metrics.
- A minimum of 5 years experience in Project Management
- Experience leading and working with cross-functional project teams is required.
- BS degree in Science discipline, higher-level degreed individuals are strongly preferred.
- A minimum of 10 years experience in pharmaceutical, medical device and or biotech industry.
- A minimum of 5 years experience in Packaging Engineering (primary, secondary and tertiary packaging).
- Experience with all applicable FDA guidelines and Quality Systems as well as ISO, USP, ISTA, IATA, ASTM standards for packaging design and validation.
- Process Excellence/Six Sigma Certification is preferred as is an ASQ Certified Quality Engineer or Auditor Certification.
- Travel: up to 90% – various client sites
Job Type: Full-time
- Packaging Engineering: 5 years