Change Control, Column Chromatography, Continuous Improvement, Corrective and Preventative Action (CAPA) Systems, Data Processing, Identify Issues, Manufacturing, Manufacturing Operations, On Call, Operational Audit, Operational Support, Operations Processes, Process Engineering
LOCATION
Lexington, MA
POSTED
12 days ago
Title: Process Engineer
Location: Lexington , MA 02421 (Hybrid)
Duration: 6+ Months (Possible extension)
Job Title : Process Engineer / Sr. Process Engineer, Downstream Process Sciences, MSAT
Worker Location : 400 Shire Way, Lexington, MA
Work Arrangement : Hybrid, 3 days on site and 2 days remote per week
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
Education and Experience
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)