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Senior Cold Chain Engineer
Job Description
ABOUT THE POSITION
The Senior Cold Chain Engineer will own the design, implementation, optimization, and continuous improvement of LN2 and temperature-controlled supply chain systems supporting research, clinical, and future commercial operations. This role is highly autonomous and requires deep technical expertise, strong project execution skills, and the ability to translate scientific and regulatory requirements into scalable operational solutions. They will be expected to be the primary supply chain contact for various internal and external teams, representing the team in many high-profile projects.
KEY RESPONSIBILITIES
Cold Chain System Design & Engineering
- Design, qualify, and optimize LN2, cryogenic, frozen, refrigerated, and CRT cold chain systems across internal and external networks.
- Lead the selection, qualification, and lifecycle management of: LN2 storage tanks and freezers, Cryogenic and passive shippers, and Temperature-monitoring devices and telemetry solutions
- Define temperature excursion tolerances, hold times, and stability-aligned packaging strategies.
Operational Readiness & Scale-Up
- Build cold chain capabilities to support R&D, clinical trials, and future commercial scale.
- Develop and execute cold chain strategies aligned with Long-term storage requirements and global distribution and site variability
- Serve as the cold chain SME during process development, tech transfer, and scale-up initiatives.
Qualification, Validation & Risk Management
- Lead cold chain IQ/OQ/PQ, lane qualification, packaging validation, and re-qualification activities.
- Author and review validation protocols, reports, and technical assessments.
- Conduct failure mode and risk analyses for cold chain processes and shipping lanes.
- Design and implement mitigation strategies for LN2 and CO2 supply interruptions, equipment failures, and transit risks.
Quality, Compliance & Documentation
- Ensure cold chain operations comply with GxP, and internal quality standards.
- Partner with Quality to develop and maintain:
- SOPs, work instructions, and deviation response playbooks
- Temperature excursion investigation frameworks
- Support audits, inspections, and regulatory readiness activities related to cold chain operations.
Vendor & External Partner Management
- Act as the technical lead for cold chain vendors, couriers, and logistics providers.
- Evaluate vendor capabilities, lead technical due diligence, and support contracting decisions.
- Drive continuous improvement through performance reviews, root-cause investigations, and CAPAs in alignment with Quality.
Data, Monitoring & Continuous Improvement
- Define KPIs and dashboards for cold chain performance (excursions, lane reliability, cost, recovery time).
- Leverage temperature data, shipment analytics, and trend analysis to proactively improve system robustness.
- Champion standardization and best-practice adoption across programs and geographies
Cross-Functional Leadership
- Serve as the cold chain subject-matter expert across Supply Chain, Manufacturing, Quality, Clinical Ops, Commercial Ops, and R&D.
- Translate scientific, regulatory, and operational needs into executable cold chain solutions.
- Independently identify gaps, propose solutions, and drive projects from concept through implementation.
- Performs other duties as assigned
QUALIFICATIONS AND EDUCATION
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the education, experience, knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Bachelor's degree in engineering, supply chain, life sciences, or related technical field (required). Master's degree in engineering, supply chain, life sciences, or related technical field (preferred).
- 7–12+ years of experience in cold chain engineering, logistics, or operations within biotech, pharma, cell/gene therapy, or biologics.
- Relevant certifications a plus: Cold Chain or GDP certifications Six Sigma / Lean methodologies
REQUIRED SKILLS AND ABILITIES
- Hands-on experience with LN2 and cryogenic cold chains (storage, shipping, and monitoring) with biologics.
- Proven track record of owning complex technical projects end-to-end with minimal oversight and ability to operate independently.
- Direct experience with packaging qualification, lane validation, and temperature excursion management.
- Proficiency in Microsoft Office Suite, DocuSign, and Smartsheet.
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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