3 engineering jobs found in Rensselaer, NY

We are looking to fill a Project Manager Validation (Fill Finish Oversight) position to our growing team. This position is responsible for providing quality oversight of validation and qualification of equipment, systems, and processes in accordance with regulatory requirements .     In this role, a typical day may include:   Responsible for compliance monitoring of area operations, including trending of failures and evaluating efficiency of corrective actions.   Generates implements and/or reviews master and completed qualification and validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications, and other applicable acceptance criteria.   Analyzes the results of testing and determines the acceptability of results against pre-determined criteria.   Investigates and troubleshoots problems which occur and determines solutions or...

The QA Validation Fill Finish team is hiring a Manager! As the Manager, QA Validation you will validate/qualify equipment, systems, and processes related to cleaning, sterilization, and Aseptic Process Simulation Validation in accordance with regulatory requirements and support, follow and implement company manufacturing standards policies and procedures. In this role, a typical day may include: L eads cross-functional teams in developing Validation best practices, standards and guidelines which includes exploring new techniques, methods, and other industry practices. Leads projects by developing appropriate plans, schedules, resource loading and other project deliverables as required Execution of validation projects and being responsible for Validation projects as well as junior-level staff. Based on engineering specification, performs validation projects which include authoring protocols, implementing validation protocols, and writing reports of validation...

We are currently looking to fill a Manager, Process Validation Oversight position. This leads a department responsible for the oversight of qualification of the equipment, systems, and processes validation for our Contract Manufacturing Organizations (CMOs) and partner groups in accordance with regulatory requirements and support, follow and implement company manufacturing standards policies and procedures.   In this role, a typical day may include: ·          Leads cross-functional teams in developing Validation best practices, standards and guidelines which includes exploring new techniques, methods, and other industry practices. ·          Leads projects by developing appropriate plans, schedules, resource loading and other project deliverables as required Execution of validation projects and overseeing Validation projects as well as junior-level staff.  Based on engineering specification, performs validation projects which include authoring...