Welcome page Returning Candidate? Log back in! Technical Operations Specialist II Job Locations US-PA-Philadelphia Job ID 2024-13370 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 conceptsAble to identify unacceptable practices and implement improvementsUnderstands basic operations and functions of equipment Understands the maintenance of equipmentWorks with vendor and clients to understand and resolve issuesUnderstands basic solution and material preparationPossesses technical knowledge and background in the pharmaceutical and biotechnology industry, ideally in cell and gene therapyPossesses basic/fundamental and working application of engineering and mechanical knowledge and is able to apply in the manufacturing areaIdeally, possesses basic and fundamental facility start-up experiencePossesses basic and fundamental understanding of technical transfer activitiesUnderstands the application of GMP concepts and is able to recommend and identify improvements as the process develops during phases of technical transferPossesses basic and fundamental understanding of validation activities and executionPossesses basic and fundamental understanding of material related activities and executionProficient on Master ControlPossesses some proficiency on NovaTekPossesses some proficiency of support systems (e.g. LIMS)Understands the concept and working application of manufacturing processes and methodsPossesses manufacturing unit operational expertiseIdentifies, 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 practicesFollows 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 issuesFollows and executes Standard Operating Procedures (SOPs)Revises, authors and provides comments as a reviewer to simple SOPsImproves the efficiency and execution of SOPsImproves the efficiency and right-first-time (RFT) of BR executionTrains others on SOPs, equipment and unit operationsMentors others on Technical Operations SOPs and systemsParticipates, provides information in the development of and authors technical documents such as non-conforming events, deviations, CAPA’s, action plans and change controlsPossess basic computer skills and able to efficiently use basic Microsoft applicationsSuggests, participates, implements and leads continuous improvement ideasIdentifies, participates, suggests solutions and leads basic and complex technical problemsIdentifies, participates, suggests with options, recommends path forward and leads basic and complex decision makingParticipates, supports, presents and represents as an SME during regulatory inspections and client auditsInteracts 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 sitePerforms well under minimal supervision and starts to work independently on complex tasks and processesPossesses lean/six sigma knowledge and experienceMay be required to work Holidays and weekendsMay be required to work outside of normal business hoursContributes to the overall operations and to the achievement of departmental goalsPerform 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 PracticesOther 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 skillsNeed to be able to read, write and understand EnglishProficient 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 PPEMust be able to work in environment with variable noise levelsAbility to stand /Sit/walk for long periods of time Ability to Lift 40 lbs routinelyAbility to crouch, bend, twist, and reachAbility to push/pull 40 lbs routinely/ often / occasionallyClarity of VisionAbility to identify and distinguish colorsMust be able to perform activities with repetitive motionsAbility to climb Ladders / Stairs / ScaffoldingAbility 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.

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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
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