Project Specialist, External Manufacturing Serialization
Biotechnology company developing medicines for serious diseases; role sits in industrial operations and product supply
| Employer | Biotechnology company developing medicines for serious diseases; role sits in industrial operations and product supply (not named) |
|---|---|
| Location | East Greenbush, NY (Capital Region) · On-site |
| Type & level | Full-time · Mid-level |
| Pay | USD 62,355–128,700 base Source: pay range stated in the source posting |
| Visa path | O-1A fit (senior candidates) |
| Role family | Principal Pharmaceutical ERP & EDI Integration Architect |
About the role
This role sits on an external manufacturing serialization team that keeps new and transferred medicines compliant with track-and-trace rules in many markets. The specialist works with contract manufacturers, third-party logistics providers and verification organizations to keep product data flowing. The posting covers several levels, from associate to senior, set by experience.
What you'll do
- Confirm serialization readiness for new and transferred products against U.S., EU and rest-of-world requirements.
- Coordinate labeling attributes, product identifiers, aggregation approaches and master data with manufacturing and logistics partners.
- Run and monitor track-and-trace platform operations, including partner connections, EPCIS/EDI message monitoring and exception handling.
- Troubleshoot data flow problems in commissioning, aggregation and decommissioning to limit supply disruptions.
- Plan and carry out computer system validation (IQ/OQ/PQ), test scripts and evidence collection for serialization systems and integrations.
- Support deviations, nonconformances, complaints and CAPAs, and own change controls and configuration baselines.
Requirements
- Bachelor's degree in engineering, supply chain or life sciences.
- Related pharma or biotech serialization, packaging and labeling experience: 0–2 years for associate, 2+ for specialist, 5+ for senior.
- Hands-on experience with track-and-trace systems and partner connectivity.
- Proven support for investigations and quality events such as deviations, complaints and CAPAs.
- Demonstrated project management skills.
Nice to have
- Experience leading end-to-end serialization implementations and product launches.
- Strong knowledge of DSCSA, EU-FMD and rest-of-world serialization rules.
- Familiarity with global standards and emerging regulations.
Pay & benefits
USD 62,355–128,700 base. The posting mentions a total rewards package that may include annual bonuses, equity awards, 401(k) company match, health, dental and vision insurance, paid time off and family support benefits.
Pay source: pay range stated in the source posting. Market data, not an offer from O1DMatch.
Visa path
Senior people in pharma serialization and supply-chain data integration often document evidence such as leading global product launches, a critical role on regulated systems, published or presented work, and high pay relative to peers. This posting states no citizenship restriction. An employer like this, or a U.S. agent, can file an O-1A petition for a qualifying candidate, though eligibility depends on the individual's record and nothing is promised.
How to get matched
- Take the free eligibility checkAn AI review of your background against the eight O-1 criteria, at check.o1dmatch.com.
- Create your profile with code WORKWITHUSIt unlocks the Starter plan at no cost. Tell us your field and the work you do today.
- Upload your evidenceEach document is sorted under the criterion it supports, and your criteria map shows what is still missing.
- Get matchedWe match strong profiles with U.S. employers hiring for roles like this one. Gigs you confirm with verified companies count toward your itinerary, and at a score of 75 we connect you with an immigration attorney.
This listing describes a real U.S. posting so you can see what employers ask for. O1DMatch does not represent that employer and does not hold this opening; applying matches you with employers hiring for this kind of role. No visa outcome is promised.
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