Software Engineer, Onboard Software, Sensors
Waabi
LinuxRust
Associate Director, Engineering – Packaging Commercialization
MSD
full-time
Posted on:
Location Type: Hybrid
Location: Rahway • New Jersey, Pennsylvania • 🇺🇸 United States
Visit company websiteSalary
💰 $126,500 - $199,100 per year
Job Level
Senior
About the role
- Lead packaging development for new products including parenteral products including small molecules, biologics, vaccines and oral solid dosage
- Define and execute overall packaging strategies that meet global network needs
- Ensure packaging system designs are robust, packaging processes are efficient, and control strategies are integrated with upstream and downstream needs
- Drive technical risk assessments, packaging specifications, and qualification activities
- Ensure compliance with regulatory standards and sustainability goals
- Represent, communicate, and balance interests of stakeholders across cross-functional teams
- Provide technical leadership, problem-solving, and project management for complex programs
- Execute activities supporting program deliverables with technical rigor and drive risk understanding and reduction prior to product launch
- Collaborate with stakeholders across end-to-end CMC areas
Requirements
- Bachelor (BS/BA) in Packaging Engineering, Packaging Science, Mechanical Engineering, or similar field with ten (10) years of relevant pharmaceutical development experience OR Master of Science (M.S.) in Packaging Engineering, Packaging Science, Mechanical Engineering, or similar field with eight (8) years of relevant pharmaceutical development experience OR PhD in Packaging Engineering, Packaging Science, Mechanical Engineering, or similar field with five (5) years of relevant pharmaceutical development experience
- Demonstrated understanding of pharmaceutical development process and ability to design, develop, and test primary and secondary packaging components
- Demonstrated understanding of Medical Device and Combination Product regulations
- Demonstrated understanding of the use of Risk Assessment tools
- Demonstrated ability to work both independently and as part of a larger team
- Demonstrated experience in leading cross-functional groups both internally and externally
- Demonstrated project management experience and ability to provide technical leadership for complex projects while managing multiple projects
- Excellent technical written and oral communication skills
- Demonstrated knowledge of current US, and global Regulations, ICH guidance, ISO standards, and quality system regulations for pharmaceutical packaging
- Strong interpersonal skills and the demonstrated ability to influence senior leaders
- Ability to manage complex programs and support multiple activities/projects
- Willingness to grow and learn all areas of Pharmaceutical new product development
- Required Skills listed: Combination Products, Compliance Packaging, Deviation Management, Engineering Standards, ISO Standard, Management Process, Mechanical Engineering, Medical Device Management, Medical Devices, Packaging Engineering, Packaging Optimization, Packaging Processes, Pharmaceutical Development, Pharmaceutical Packaging, Risk Management, Technical Leadership
- Preferred: Medical Device and Combination Product Packaging development experience; Quality by Design (QbD) experience; Experience defining standard work processes and documents; Experience specifying, processing and characterizing packaging materials including rigid and flexible barriers, pulp/paperboard and recyclables
- US and Puerto Rico Residents Only (hiring location restriction)
- VISA Sponsorship: No
- Relocation: No
Benefits
- eligible for annual bonus and long-term incentive, if applicable
- comprehensive package of benefits
- medical, dental, vision healthcare and other insurance benefits (for employee and family)
- retirement benefits, including 401(k)
- paid holidays
- vacation
- compassionate and sick days
- Flexible Work Arrangements: Hybrid (U.S. Hybrid Work Model)
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
Packaging EngineeringPackaging ScienceMechanical EngineeringPharmaceutical DevelopmentRisk AssessmentProject ManagementTechnical LeadershipPackaging OptimizationMedical Device ManagementQuality by Design (QbD)
Soft skills
Technical CommunicationInterpersonal SkillsProblem-SolvingTeam CollaborationStakeholder ManagementInfluencing SkillsIndependent WorkLeadershipOrganizational SkillsAdaptability
