BridgeBio
Overview
Applying for this role is straight forward Scroll down and click on Apply to be considered for this position. 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.
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Applying for this role is straight forward Scroll down and click on Apply to be considered for this position. 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