Specialist, Manufacturing Science and Technology (MSAT) – Monroe, NC: Design, develop, test, and evaluate integrated systems for handling effectively pharmaceutical production processes. Supporting process owners in the manufacturing, equipment training, maintenance issues and troubleshooting for smooth production activities. Investigating, gathering, and analyzing data to resolve Issues/ Action Items. Extended support to CFT teams supports to change controls, investigations, deviations and CAPAs. Assisting in site validation efforts to meet company’s business and regulatory specifications. Participate in the preparation and review of SOP for Qualification of facility, utility and equipment (FUE), Risk assessment, cGMP impact assessment, gap assessment, change control, and deviation. Preparation, execution and reviewing of the IOPQ qualification documents. Working on sterilization and aseptic processing validations. Preparation, review, execution and compilation of cycle development studies and performance qualification for Autoclave. Handling air visualization study and grade recovery study. Handling risk assessment evaluation activity for preparing the intervention study under grade A classification. Use of KAYE AVS software setup, calibration verification and qualification used for Sterilizer qualification. Preparing and executing major equipment such as ORABS, Vial line, Pre-Filled Line (PFS), PFS labeler, Air Handler Units, Laminar Air flow units, EMS, RADIX. Preparing and approving preventive maintenance activity, calibrations.

Qualifications and Requirements:

• Applicant must have a Master’s Degree (or U.S. equivalent) in Validation Engineering, Industrial Engineering or related field plus 2 years of experience in Validation and Process Engineering in the pharmaceutical industry.
• Or in the alternative to all the job requirements set forth above, the employer will accept a Bachelor’s Degree (or U.S. equivalent) in Validation Engineering, Industrial Engineering or related field plus 5 years of experience in Validation and Process Engineering in the pharmaceutical industry.
• Must have experience with cleaning validation, process and utility systems validation, temperature mapping, manufacturing equipment qualification & validation.
• Hands-on experience in planning and creation of schedules for preventive maintenance and calibration of critical equipment and instruments used in utility and production area, Air Handling and Roof Top Units.
• Hands on experience obtaining documentation necessary for change controls, deviations and other GMP documents; and the respective reviews documentation for accuracy and completeness.
• Knowledge of validation documentation for manufacturing, packaging, and facility equipment’s (HVAC, RTU, Utilities) and systems according to the GAMP4 validation Life cycle (URS, DS, Software and Hardware), Commissioning, FAT, IQ, OQ, PQ and reports.
• Must have experience in the successful execution of IQ, OQ, PQ of equipment’s and validation’s of plant utilities.

40 hours per week: M-F. 9am-5pm. Must have proof of legal authority to work in the United States.

To be considered, please visit Glenmark Pharmaceuticals’ career site website at https://glenmarkpharma-us.com/careers-at-glenmark/career-search/ to create a profile and submit a resume. Job# 20240105