What are the responsibilities and job description for the Senior Packaging Engineer position at Aditi Consulting?
Payrate: $43.00 - $45.20/hr.
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.
Basic Qualifications:
- 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.
Preferred Qualifications:
- 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
Must Have Skill:
- On-Site at ATO
- Packaging Engineering Experience
- Experience with Paper-Based Packaging
Pay Transparency: The typical base pay for this role across the U.S. is: $43.00 - $45.20 /hour. Non-exempt positions are eligible for overtime at a rate of 1.5 times the base hourly rate for all hours worked in excess of 40 in a work week, or as required by state or local law. Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education and experience. Full-time employees are eligible to select from different benefits packages. Packages may include medical, dental, and 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, and discretionary performance or recognition bonus. Sick leave and mobile phone reimbursement provided based on state or local law.
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Salary : $43 - $45