Packaging Engineer
Location:Petaluma, CA
Employment Type:Contract-to-hire
Industry:Biotechnology, Pharmaceuticals, and Medical Devices
Position Summary
Our client in Petaluma is seeking aPackaging Engineerwith strong experience in packaging validation and regulated pharmaceutical, biotechnology, or medical device environments.
The Packaging Engineer will lead the development, qualification, validation, and continuous improvement of packaging systems for products that may include pharmaceutical formulations, medical devices, combination products, and antimicrobial solutions. This individual will work cross-functionally with R&D, Quality, Regulatory, Manufacturing, and external suppliers to ensure packaging systems protect product quality, maintain sterility or product integrity when applicable, support shelf-life requirements, and meet applicable regulatory and industry standards.
The ideal candidate is hands-on, detail-oriented, and comfortable working in an evolving environment where priorities can shift as products move from development through clinical, manufacturing, and commercial stages.
Key Responsibilities:
Lead packaging development activities from early concept through design transfer, process qualification, and commercial launch.
Develop packaging specifications, drawings, bills of materials, component requirements, and packaging-related design inputs and outputs.
Design and execute packaging validation strategies, protocols, reports, and supporting documentation.
Develop and manage validation activities such as:
Package integrity and seal-strength testing
Distribution and transportation testing
Environmental conditioning
Accelerated and real-time aging
Sterilization or aseptic packaging evaluations, as applicable
Compatibility and material interaction studies
Shipping configuration and handling assessments
Support the selection and qualification of primary, secondary, and tertiary packaging materials and components.
Evaluate packaging systems for compatibility with pharmaceutical formulations, medical devices, antimicrobial products, and other product-contact materials.
Partner with Quality and Regulatory teams to ensure packaging documentation supports applicable FDA, ISO, GMP, and other regulatory requirements.
Prepare and maintain packaging risk assessments, including design FMEAs, process FMEAs, hazard analyses, and risk-control documentation.
Support packaging-related investigations, nonconformances, CAPAs, deviations, and change controls.
Collaborate with contract manufacturers, packaging suppliers, test laboratories, and sterilization providers.
Develop packaging test methods and acceptance criteria based on product requirements, intended use, and risk.
Support line trials, packaging equipment evaluations, manufacturing scale-up, and process optimization.
Provide technical guidance on package labeling, component specifications, artwork implementation, and product configuration.
Create and maintain technical reports, protocols, validation master plans, work instructions, and standard operating procedures.
Assist with design reviews, technical assessments, product risk reviews, and regulatory submissions.
Identify opportunities to improve packaging reliability, manufacturability, sustainability, cost, and supply continuity.
Communicate project status, technical risks, timelines, and recommendations to cross-functional stakeholders.
Required Qualifications:
Bachelor’s degree in Packaging Engineering, Mechanical Engineering, Chemical Engineering, Materials Science, Biomedical Engineering, or a related technical discipline strongly preferred.
Experience developing and validating packaging for pharmaceutical, biotechnology, medical device, combination product, or other regulated products.
Demonstrated experience with packaging validation, qualification, and technical documentation.
Working knowledge of GMP, FDA quality-system expectations, and applicable medical device and pharmaceutical packaging standards.
Experience with packaging integrity, seal-strength, aging, distribution, and transportation testing.
Ability to interpret technical specifications, drawings, test reports, and supplier documentation.
Strong problem-solving and root-cause analysis skills.
Excellent written and verbal communication skills.
Ability to manage multiple projects and work effectively in a collaborative, fast-paced environment.
Strong attention to detail and commitment to documentation accuracy.
Preferred Qualifications:
Experience with sterile barrier systems, aseptic packaging, or sterilization processes.
Experience with pharmaceutical liquid, topical, wound-care, inhalation, or antimicrobial products.
Experience with medical device, drug-device combination, or clinical packaging.
Familiarity with ISO 11607, ASTM packaging test methods, ISTA distribution testing, and related industry standards.
Experience with package integrity methods such as dye penetration, bubble leak, vacuum decay, microbial ingress, burst testing, or tracer-gas testing.
Experience supporting container-closure integrity evaluations.
Knowledge of packaging materials including plastics, films, foils, glass, elastomers, adhesives, coatings, and molded components.
Experience working with contract manufacturers and external testing laboratories.
Familiarity with design controls, design transfer, change control, CAPA, and document-control processes.
Experience in an early-stage or growing biotechnology, pharmaceutical, or medical device company.
Success in this position will include:
Establishing robust, scientifically justified packaging validation strategies.
Delivering compliant packaging documentation that supports product development and regulatory milestones.
Ensuring packaging systems protect product quality, safety, stability, and usability.
Helping transition products from R&D into reliable, scalable manufacturing processes.
Building strong working relationships across engineering, science, quality, regulatory, manufacturing, and supplier teams.
Identifying and resolving packaging risks before they affect clinical, manufacturing, or commercial objectives.
This is an opportunity to join a science-driven company working on technologies designed to address important challenges in infection prevention and healthcare. As an early member of the team, the Packaging Engineer will have the opportunity to: Make a direct contribution to the development of products with potential medical and public-health applications, Work closely with scientific, engineering, quality, regulatory, and manufacturing leaders, Gain broad experience across product development, validation, clinical readiness, and commercialization, Help establish packaging systems and processes as the company scales, Take on increasing technical responsibility and leadership as the organization grows, Work with innovative antimicrobial technologies and products intended for demanding healthcare environments- and much more!
Compensation will be commensurate with experience and qualifications. The initial position is structured as contract-to-hire, with the potential for transition to a full-time role based on business needs, performance, and mutual fit. Any benefits, equity, incentive, or profit-sharing opportunities will be provided in accordance with company policy and applicable offer terms.
As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources.
Please note: The following benefits reflect Kelly's general offerings. Eligibility may vary by assignment, location, and job type. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.
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