Technical Operations Specialist III

Overview

Job Summary: Responsible for generating and/or review manufacturing related technical documents and manage timely closure of these documents.  This includes but is not limited to Non-Conforming Event (NCE) investigations, CAPAs, Change Controls (CC), Batch Records (BR), Technical Transfers (TT), Final Reports (FR), and Standard Operating Procedures (SOP).  

Responsibilities

Essential Job Functions:

• Understands aseptic technique concepts
• Able to identify unacceptable practices and implement improvements
• Understands basic operations and functions of equipment 
• Understands the maintenance of equipment
• Works with vendor and clients to understand and resolve issues
• Understands basic solution and material preparation
• Possesses technical knowledge and background in the pharmaceutical and biotechnology industry, ideally in cell and gene therapy
• Possesses basic/fundamental and working application of engineering and mechanical knowledge and is able to apply in the manufacturing area
• Ideally, possesses basic and fundamental facility start-up experience
• Possesses basic and fundamental understanding of technical transfer activities
• Understands the application of GMP concepts and is able to recommend and identify improvements as the process develops during phases of technical transfer
• Possesses basic and fundamental understanding of validation activities and execution
• Possesses basic and fundamental understanding of material related activities and execution
• Proficient on Master Control
• Possesses some proficiency on NovaTek
• Possesses some proficiency of support systems (e.g. LIMS)
• Understands the concept and working application of manufacturing processes and methods
• Possesses manufacturing unit operational expertise
• Identifies, participates, understands and able to explain the ‘why’ of acceptable and unacceptable practices, is able to make suggestions to improve performance 
• Performs basic and complex analysis, interprets, and draws conclusion of scientific and process data per good document practices
• Follows compliance and regulatory requirements and current Good Manufacturing Practices (cGMPs) and understands ‘why’ behind the regulations.  
• Identifies, communicates, addresses and improves simple and complex cGMP compliance and regulatory gaps and issues
• Follows and executes Standard Operating Procedures (SOPs)
• Revises, authors and provides comments as a reviewer to simple SOPs
• Improves the efficiency and execution of SOPs
• Improves the efficiency and right-first-time (RFT) of BR execution
• Trains others on SOPs, equipment and unit operations
• Mentors others on Technical Operations SOPs and systems
• Participates, provides information in the development of and authors technical documents such as non-conforming events, deviations, CAPA’s, action plans and change controls
• Possess basic computer skills and able to efficiently use basic Microsoft applications
• Suggests, participates, implements and leads continuous improvement ideas
• Identifies, participates, suggests solutions and leads basic and complex technical problems
• Identifies, participates, suggests with options, recommends path forward and leads basic and complex decision making
• Participates, supports, presents and represents as an SME during regulatory inspections and client audits
• Interacts frequently with support groups 
• Regularly coordinates with groups 
• Cross trains in other areas and may be utilized to perform above job functions across the entire site
• Performs well under minimal supervision and starts to work independently on complex tasks and processes
• Possesses lean/six sigma knowledge and experience
• May be required to work Holidays and weekends
• May be required to work outside of normal business hours
• 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 

• High School diploma and over 4-6 years of relevant experience or  
• Associates’/Bachelor’s (science preferred) degree with 1-2 years of relevant or equivalent experience

 

Knowledge / Skills / Abilities:

• Ability