WuXi AppTec

Senior Pilot Plant Operator

Job Locations US-CA-San Diego
Job ID
2021-8392

Overview

Participates in the execution of chemical processes for the preparation of raw materials, starting materials, intermediates, and API in the Kilo-Lab (Process Room suites) and Pilot Plant in compliance with cGMP regulations (as required). This typically includes acting as lead operator for a given process in the Pilot Plant, but may also include acting as a technical supervisor and may include participating on a process in the Kilo Lab suites. Also responsible for keeping the Pilot Plant equipment and suites functional and compliant, as well as participating in Materials Management.

Responsibilities

  • Participates in the execution of chemical processes in the Pilot Plant.
  • Provides technical and trouble-shooting support for Pilot Plant processes.
  • Assists with preparation of Standard Operating Procedures (SOPs) for the Pilot Plant.
  • Interacts with Facilities, Analytical Development, Chemical Development, EH&S, and Quality groups in an effective manner.
  • Works with Facilities to schedule repairs and updates to the Pilot Plant equipment and suites.
  • As applicable, attentive interaction expected with equipment/material vendors and clients.
  • Manages inventory for consumables and equipment as needed, as well as management of raw material and starting material inventory for chemical processing in the Pilot Plant.
  • Evaluates current procedures and equipment in the Pilot Plant for continuous improvement, responsible for revising related procedures, and initiation a plan for any identified improvements.
  • Training of Operations Technicians (as required) to be competent in cGMP and EH&S procedures, as well as the chemical processes to be carried out per the specific batch records.
  • Ensures cGMP compliance of the Pilot Plant and associated equipment, as well as the corresponding production processes and products.
  • Contributes to the overall operations and to the achievement of departmental goals
  • Perform job specific tasks in compliance with applicable Regulations, International Standards, and WuXi AppTec Policies and Standard Operating Procedures.
  • Thorough understanding of Good Laboratory Practices and Good Manufacturing Practices
  • Other duties as assigned
  • May be required to assist in other departments

Qualifications

Experience / Education   

  • Bachelors of Science degree in Chemistry or a related discipline preferred.
  • 3-5 years of relevant experience..

 

Knowledge / Skills / Abilities:

  • Demonstrated capability in organic chemical process development, scale-up, Pilot Plant processing operations, and cGMP operations.
  • Effectively demonstrate document revision/creation/review required.
  • Must be able to use and maintain large-scale Pilot Plant equipment.
  • Must be able to lead production projects with less experienced Operations Technician(s).
  • Responsible for providing technical and trouble-shooting support to Pilot Plant processing.
  • Participates in execution of chemical processes in the Pilot Plant suites and supervises/trains Operations Technicians during execution.
  • May manage the inventory for large-scale chemical processing (consumables, equipment, materials, etc.)
  • Responsible for keeping the Pilot Plant functional and compliant
  • Effective communication (both oral and written) required to interact with Facilities, Analytical Development, Chemical Development, EH&S, and Quality to accomplish goals.

 

Physical Requirements:          

  • Must be able to work typical variable M-F 8-hour shifts from 7am-7pm and occasional weekends, afterhours, and overtime based on business needs.
  • Must be able to work in an office environment with minimal noise conditions.
  • Must be able to work in Lab setting with exposure to various Chemicals and unknown hazardous materials.
  • Must be able to wear appropriate PPE especially full-face respirators and PAPRs.
  • Must be able to work in environment with variable noise levels
  • Ability to stand /Sit/walk for long periods of time
  • Ability to Lift 50 lbs. routinely
  • Ability to crouch, bend, twist, and reach
  • Ability to push/pull routinely/ often / occasionally 55-gal liquid filled drums.
  • Clarity of Vision
  • Ability to identify and distinguish colors
  • Must be able to perform activities with repetitive motions
  • Ability to climb Ladders / Stairs / Scaffolding
  • Inside/outside working conditions

 

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability

 

This job description does not state or imply that the above are the only duties and responsibilities assigned to this position.  Employees holding this position will be required to perform any other job-related duties as requested by Management.

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