Process Engineer - Hightstown, United States - Synerfac

Description

• Responsible for maintaining all manufacturing equipment (washing, sterilization tunnel, vial filling and capping machine, Lyophilizer, Autoclave, packaging machines and plant utility systems including, heating, ventilating and air conditioning systems (HVAC).
• Upkeep of the plant including clean rooms and clean utilities (purified water system, WFI generation system, pure steam generation system /plants including control systems.
• Day to day engineering support across functional department for continuous operation.
• Documentation for routine maintenance and records as per cGMP requirement.
• Schedule activities based on priorities and ensure all documentation is compliant with Good documentation practices.
• Understand quality systems including Change Control, Deviations, CAPA"s and FMECA.

• Plan calibrations activities with internal /external agencies as applicable.
• Increase Safety Awareness and address any safety issues and concerns and ensures that equipment meets all relevant Health, Safety and Environment requirements.
• Participate in validation activities and their documentation such as Validation Summary Report (VSR) as per GXP Regulations (GMP, GAMP).
• Optimize the process by introducing new technology, automation and their implementation.

• Responsible for the entire life cycle of equipment Validation including User Requirements Specifications (URS), Functional Requirements Specifications (FRS) Vendor Assessment and System Design Specifications (SDS).

• 4 Years of related experience in the Pharmaceutical Sector
• Ability to upkeep the Manufacturing & Facility equipment's and related documentation.
• Process optimization by introducing new technology, automation, and their effective implementation.
• Experience with Microsoft Office products, such as Excel, Word, and Outlook.
• Able to write SOP (standard operating procedure) using equipment manuals and executing IQ/OQ/PQ protocols.
• Ability to work independently with minimal direction and supervision.
• Must be able to communicate effectively with departmental staff, both written and verbal.
• A strong work ethic, integrity, stability, sense of urgency, fairness, and a desire and willingness to take ownership and assume responsibility for the operation.
• Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take transfer sponsorship of an employment Visa at this time