• Senior Validation Engineer, Manufacturing Technical Services

    Location US-IL-Chicago
    Posted Date 3 months ago(3/22/2018 9:23 AM)
    ID
    2018-2125
    Company
    Adello Biologics, LLC
  • Overview

    Adello Biologics is a privately held, U.S.-based biotechnology company that leads with science to accelerate development and drive manufacturing efficiency. The company's aim is to provide high-quality, affordable biosimilars to patients worldwide. Headquartered in Piscataway, NJ and driven by a team of highly skilled industry veterans, Adello is advancing a strategic pipeline of proteins and complex monoclonal antibodies with lead candidates in oncology and immunology. For more information, visit www.Adellobio.com

     

    Our vision is to make biosimilar medications affordable. We are seeking candidates interested in contributing to a bourgeoning field that has the potential to help millions of patients. As a growing company, Adello Biologics offers real development opportunities for candidates excited to take on responsibility, make an immediate impact and help us achieve our vision. As part of a close knit team, you’ll have the opportunity to work in a unique, high science industry while expanding your career. We are seeking a Senior Validation Engineer, Manufacturing Technical Services  to be based out of our Chicago, IL location.

    Responsibilities

    SUMMARY:

    The Senior Validation Engineer is a regular employee in a full-time exempt position at Adello Biologics, LLC, in Chicago, IL. This position will report directly to the Validation Manager and support various functional areas within Adello.

     

    Essential Duties and Responsibilities:

    • Write and Develop Equipment/Facility/Utility and Instrument Qualification protocols (first in kind) and Validation/Qualification Policies.
    • Initiate an own Change Controls; provide validation assessments and remediation plans as required by the system/equipment/components.
    • Establish Qualification/Validation departmental requirements and procedures.
    • Develop Commissioning and Qualification Plans.
    • Develop URS, FS, DQ documents and qualification protocols (IQ/OQ/PQ) to ensure compliance with 21CFR Part 210 and 211 and adherence to ICH Q7.
    • Lead Risk-Based evaluations, utilize Risk Assessment Methods/tools, and provide technical input during FMEA processes.
    • Lead discussions and provide guidance to personnel during risk assessments.
    • Assure adherence to Q9 “Quality Risk Management”.
    • Assure Compliance with FDA and EU Regulations.
    • Evaluate, document, and develop investigations attributed to qualifications failures.
    • Author Summary Reports, events, and applicable protocol amendments.
    • Execute and/or provide support during protocol executions.
    • Assure all the qualification items are tracked and successfully completed.
    • Perform GAP analysis and provide recommendations for existing qualifications.
    • Ability to work in a fast pace environment.
    • Technical problem solving ability, manage multiple priorities, provide logical and analytical reasoning, technical writing ability, and self-training.
    • Candidate must adapt the work schedules to perform required qualification activities. This may require overnight and/or weekends.

     

    Examples of Validation/Qualification support needed:

    • Software Validation
    • Automated system and controllers’ qualification
    • Chromatography skids, AKTA controllers qualification
    • Laboratory equipment qualification (spectrophotometers, HPLC, GC, scales, LC-MS)
    • Freezers, Chambers, Refrigerators, Cold Rooms, Walking Freezers qualification
    • Cell counters
    • Laminar Flow Hood, Fume Hood, Biosafety Cabinet qualification
    • Filler, Capper, filling line/equipment qualification
    • Container Closure Leak Tester qualification

    Qualifications

     

    PREREQUISITES:

    Education:

    • BS or MS Degree in Education in Engineering, Microbiology, Biotechnology, Chemical or related field.

    Experience:

    • At Least 4 Years of experience in computer validation and automated systems
    • At least 8 years’ experience commissioning, validation and qualification of Equipment/Facilities/Utilities and Processes using Risk Based approach and leverage strategies.

     

    SPECIALIZED KNOWLEDGE AND SKILLS:

    • Abe to work in a fast pace environment.
    • Technical problem solving, handle multiple priorities, perform well under stressful situations, think fast, logical and mathematical reasoning, technical reading interpretation and self-training.
    • The candidate must adapt the work schedules to perform required qualification activities. This may require to work overtime, overnight or on weekends.

     

     WORK ENVIRONMENT AND PHYSICAL DEMANDS:

    General Work Environment:

    • Work in machinery rooms, clean rooms, and laboratories.
    • Work at a desk doing computer work (reading, editing, writing document) is also required.

     

    Noise:

    • No extraordinary noise levels.

     

    Standing/Lifting:

    • Must be able to move around the facility to reach various equipment.
    • Must be able to lift at least 25 lbs.

    Visual:

    • No special requirements

     

    Stress:

    • High paced demanding environment to meet ambitious project goals.

     

    Travel:

    • Travel not expected.

    Adello Biologics, LLC provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability or genetics. In addition to federal law requirements, Adello Biologics, LLC complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training

     

    Notice To Agency And Search Firm Representatives  

    Adello Biologics is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Adello employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Adello. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

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