Sr. Process Engineer, Downstream Process Sciences, MSAT
Job in
Lexington, Middlesex County, Massachusetts, 02421, USA
Listed on 2026-07-01
Listing for:
LanceSoft Inc
Full Time
position Listed on 2026-07-01
Job specializations:
-
Engineering
Validation Engineer, Process Engineer, Regulatory Compliance Specialist
Job Description & How to Apply Below
Job Description (include education requirements and years of experience needed)
- Support ongoing purification operations on the manufacturing floor, including Capture step operations, filtration (NF, UF/DF) unit operations, chromatography column performance/integrity and drug substance formulation/bottling
- Troubleshoot process issues
- Monitor and evaluate process operation data for downstream operations
- Provide on-call coverage on a rotation to support MFG operation
- Collaborate with manufacturing staff to find ways to continuously improve the consistency and robustness of process operations
- Support Quality System with consistent and well documented response to process operations events to support investigations, deviation closure as well assistance to change control/CAPA as appropriate
B.S. with minimum 6 years of relevant industry experience (downstream PD or MSAT preferred)
M.S with minimum 3 years of relevant industry experience (downstream PD or MSAT preferred)
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