Director, Manufacturing Engineering

PelicanMaple Grove, MN
20h

About The Position

Peli BioThermal offers the widest range of temperature-controlled packaging and service solutions to the global life sciences industry. The company’s products ensure that delicate biological materials arrive intact and effective, despite exterior environments. Peli BioThermal is dedicated to developing innovative products designed to fulfil the complex needs of the global life sciences industry. The company’s customers benefit from its extensive expertise in ensuring that temperature stability is maintained throughout the distribution chain. The company also offers a complete portfolio of services and software to support end-to-end temperature-controlled packaging asset management. At Peli BioThermal, your work has a real-world impact. You’ll be part of a team driven by innovation, craftsmanship, and the shared belief that when the mission is critical, failure isn’t an option. If you’re ready to build something that makes a difference, be part of a team that protects what matters most. The Director, Manufacturing Engineering provides strategic and technical leadership across the global engineering group, ensuring consistent execution of equipment sourcing, installation, and validation of manufacturing, conditioning and assembly processes while leading a diverse, multidisciplinary engineering team. The role bridges site-level execution and strategy, supporting global scalability, compliance, and product performance.

Requirements

  • A bachelor’s degree in engineering (mechanical, industrial, manufacturing)
  • 10+ years of experience in manufacturing including validation, with a proven track record of managing cross functional, global teams
  • Minimum of 5 years in a senior leadership role
  • Proven ability to lead validation strategy and a deep knowledge of manufacturing and process methodology
  • Proven ability to lead strategic transformation, manage budgets and align manufacturing operations with business goals

Responsibilities

  • Lead global manufacturing and process strategy, ensuring alignment across regions and sites.
  • Establish global standards for, included but not limited to, validation (equipment and process), product conditioning, assembly processes and material handling.
  • Drive consistent performance against global KPIs.
  • Partner with regional operations leaders to balance local execution with global standardisation.
  • Own global process engineering and validation strategy for the division
  • Ensure robust and consistent equipment and process qualification (IQ/OQ/PQ) across sites for all conditioning equipment and process.
  • Maintain global control of validated states through change control, requalification, and continued process verification.
  • Provide technical oversight for deviation investigations, root cause analysis, and CAPAs related to conditioning and packaging processes.
  • Lead a globally distributed, multidisciplinary engineering organization including process and manufacturing engineering.
  • Define global technical governance, engineering standards, and best practices.
  • Develop organisational capability through talent development, succession planning, and knowledge sharing across regions.
  • Align engineering priorities with manufacturing execution, quality requirements, and business objectives.
  • Ensure global compliance with all relevant standards, and customer-specific requirements.
  • Serve as a senior technical authority during global customer audits, qualification activities, and complex programs.
  • Support global customer onboarding and thermal qualification initiatives with manufacturing and process expertise.
  • Ensure data integrity, documentation consistency, and inspection readiness across all sites.
  • Contribute to global capital planning for conditioning equipment, capacity expansion, and site redundancy.
  • Evaluate and implement new technologies, automation, and digital monitoring tools to enhance global process robustness.
  • Lead Lean manufacturing and operational excellence initiatives across the global network.
  • Drive standardization and scalability of processes to support growth and resilience.
  • Performs additional duties as assigned.

Benefits

  • Competitive paid time off plans/Holiday pay/extra vacation purchase opportunities
  • 401k plan – with immediate match
  • Great Benefits – several options including Pet insurance for our animal lovers.
  • Health Savings Account Contribution
  • Wellness Discount Program
  • Global Mental Wellness Program
  • Quarterly Employee Celebration Days
  • Peer to Peer Recognition Program
  • Service Recognition Program
  • Amazing employee discount program on Pelican Products, Pelican branded apparel and gear
  • Employee referral program – get paid to work with your trusted network.
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