Overview
Packaging Engineer 3 at BridgeBio. This role provides technical and process support for commercial and clinical drug product packaging operations at BridgeBio CPOs, coordinating commercial primary/secondary packaging engineering operations and serialization, and ensuring cGMP compliance at drug product contract manufacturers.
Base pay range
$110,000.00/yr - $135,000.00/yr
What You'll Do
The Packaging Engineer 3 reports directly to the Director, Pharmaceutical Packaging. Responsibilities include serving as the BridgeBio technical contact for Drug Product Packaging, leading efforts to implement package/labeling design, serialization, and shipping validation; coordinating with CMOs, component suppliers, and related design service providers; and ensuring timely completion of operations and documentation.
- Lead packaging design/serialization activities and oversee shipping validation with CMOs and suppliers
- Coordinate with BridgeBio Affiliate Drug Product, Analytical Chemistry, Quality Assurance, Regulatory Assurance, and Supply Chain Management and contract manufacturers
- Review and route master batch records (MBRs), SOPs, Change Controls, tech transfer reports, validation master plans, and commercial labeling documentation
- Support DP Packaging activities at contract packaging sites, including material verification, direct shipment, and related reports
- Aid in managing BridgeBio commercial serialization and act as SME as needed
- Travel to contract manufacturers or business partners as required (approx. 15%)
- Provide regulatory filing support (IND, IMPD, NDA, MAA, etc.)
- Maintain training status on BridgeBio and Affiliate SOPs
- Support investigations related to DP Packaging or shipping operations
- Monitor cGMP compliance at drug product contract manufacturers to protect product integrity and company reputation
Knowledge, Skills, And Abilities
- Technical knowledge of commercial-scale OSD pharmaceutical packaging and labeling (primary, secondary, tertiary)
- Serialization experience with DSCSA and familiarity with Tracelink or similar providers is highly desirable
- Knowledge of ISTA/ASTM distribution testing standards
- Experience with TOPS and/or CAPE palletizing software is desirable
- Ability to author technical protocols, reports, and assessments
- Experience collaborating with CMOs/CPOs and external vendors
- Strong problem-solving, cross-functional collaboration, and communication skills
- Broad regulatory knowledge (cGMP, FDA, ICH, EU) and ability to provide regulatory filing support (IND/IMPD, NDA, MAA, etc.)
- Knowledge of packaging materials and leadership in material selection and implementation
Where You'll Work
A hybrid role is preferred, requiring in-office collaboration 2–3x per week in our San Francisco Office. A remote option may be considered based on the candidate.
Who You Are
A minimum of 5 years of relevant pharmaceutical industry experience is required. A B.S. degree in package engineering or a related scientific field is desirable.
- Prior experience in a pharmaceutical company in a packaging engineering role
- Experience with cGDP documentation, change control, and quality systems (e.g., Veeva, MasterControl, eQMS) required
- Direct experience with serialization solutions (e.g., Tracelink, Systech) desired
- Experience collaborating with CMOs in a virtual company is desired
- Experience with global product launches and CMC regulatory requirements is desired
Rewarding Those Who Make The Mission Possible
BridgeBio offers a market-competitive total rewards package, including base pay, annual performance bonus, company equity, and health benefits.
Financial Benefits
- Market leading compensation
- 401K with employer match
- Employee stock purchase program
- Pre-tax commuter benefits
- Referral program with $2,500 award for hired referrals
Health & Wellbeing
- Comprehensive health care with premiums covered for employee and dependents
- Mental health support via Spring Health
- Hybrid work model; flexible paid time off; parental leave
- Flexible spending accounts and group term life & disability insurance
- Subsidized meals on days in the office
Job Details
- Seniority level: Mid-Senior level
- Employment type: Full-time
- Job function: Engineering and Information Technology
Referrals increase your chances of interviewing at BridgeBio. Get notified about new Packaging Engineer jobs in San Francisco, CA.
#J-18808-Ljbffr