Aditi Consulting · 7 hours ago
Senior Packaging Engineer
Aditi Consulting is seeking a Senior Packaging Engineer to lead the development and optimization of packaging for biologics and sterile injectables. The role involves creating specifications, ensuring regulatory compliance, and collaborating with cross-functional teams to support manufacturing readiness and continuous improvement efforts.
AppsConsultingInformation TechnologySoftware Engineering
Responsibilities
Lead development and optimization of secondary & tertiary packaging packaging for biologics, sterile injectables, and combination products (e.g., prefilled syringes, autoinjectors)
Create and maintain component specifications for vials, stoppers, syringes, seals, cartons, labels, and distribution packaging
Develop and execute packaging test protocols including: Transportation simulation (ISTA/ASTM), Aging and self-life studies, Cold-chain and environmental conditioning, Packaging line engineering studies
Ensure compliance with global regulatory expectations (FDA, EMA, ISO 11607)
Prepare and review packaging documentation for regulatory submissions
Support tech transfer, scale-up, and readiness activities at manufacturing sites and CMOs
Lead investigations into packaging deviations, component failures, and operational issues; drive CAPA and continuous improvement
Partner with suppliers and Procurement to qualify components, assess supplier capability, and manage change notifications
Represent Packaging Engineering on cross-functional project teams, ensuring alignment with design control and DHF requirements
Qualification
Required
Bachelor's degree in Packaging Engineering, Mechanical Engineering, Materials Science, Chemical Engineering, Biomedical Engineering, or related field
7+ years of packaging engineering experience in biopharmaceutical, pharmaceutical, or medical device environments
Strong understanding of cGMP, sterile product packaging, and biologics/combination product considerations
Experience with packaging validation and ISTA/ASTM distribution testing
Excellent communication skills and ability to collaborate across functions
On-Site at ATO
Packaging Engineering Experience
Experience with Paper-Based Packaging
Preferred
Master's degree in engineering or related field
Experience with combination products, injection devices, and cold-chain distribution systems
Knowledge of paperboard, structural design & FEA
Benefits
Medical
Dental
Vision benefits
Health savings accounts with qualified medical plan enrollment
10 paid days off
3 days paid bereavement leave
401(k) plan participation with employer match
Life and disability insurance
Commuter benefits
Dependent care flexible spending account
Accident insurance
Critical illness insurance
Hospital indemnity insurance
Accommodations and reimbursement for work travel
Discretionary performance or recognition bonus
Sick leave
Mobile phone reimbursement
Company
Aditi Consulting
Aditi Consulting is a firm that stays abreast of offering technological solutions, project management and digital transformation.
H1B Sponsorship
Aditi Consulting has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (55)
2024 (44)
2023 (25)
2022 (26)
2021 (24)
2020 (30)
Funding
Current Stage
Late StageRecent News
bloomberglaw.com
2025-10-16
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