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 Overtime
• 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 to accurately and reproducibly perform arithmetic calculations including fractions, decimals and percentages and basic algebraic and geometric calculations.
• Clarity of vision at near and mid-ranges (less than 20 feet), depth perception and ability to identify and distinguish colors.
• Must be able to wear appropriate clean room attire (i.e. surgical masks) and all Personal Protective Equipment (PPE).
• Works in production environment with exposure to latex and bleach. Potential exposure to noise and equipment hazards (i.e. vacuum pumps, pressurized vessels), dangerous materials (i.e. chemicals, solvents, pathogens), freezer burns, allergens and strong odors.
• Based on work assignment, may be recommended to have medical testing in accordance with the company's Occupational Health Program.
• Holiday and shift work often required based on manufacturing schedule as determined by Management.
• Proficient in Oral & Written communication skills
• Need to be able to read, write and understand English
• Proficient in Microsoft (Excel, Word, Outlook)

Physical Requirements:

• Must be able to work in an office environment with minimal noise conditions.
• Must be able to work in Lab setting with Biohazards /various Chemicals
• Must be able to wear appropriate PPE
• Must be able to work in environment with variable noise levels
• Ability to stand /Sit/walk for long periods of time
• Ability to Lift 40 lbs routinely
• Ability to crouch, bend, twist, and reach
• Ability to push/pull 40 lbs routinely/ often / occasionally
• Clarity of Vision
• Ability to identify and distinguish colors
• Must be able to perform activities with repetitive motions
• Ability to climb Ladders / Stairs / Scaffolding
• Ability to work in variable temperatures high to freezing
• 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.