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    Validation Specialist - sterile exp from manufacturing pharma env

    Media Company
    Monroe, NC 28110
    Full-time, Part-time
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    Job Description

    Job Description

    No Visa sponsorship

    Must have Sterile Experience from pharma manufacturing environment

    Key Responsibilities:

    · Qualification of Oral Solid Dose (OSD) and Sterile manufacturing facilities.

    · Maintain all documentation pertaining to qualification and validation.

    · Experience in Equipment and Facility Validation and / or Qualification in GMP environment. This position will interface with clients, lead teams of validation professionals, and provide subject matter expertise in the validation of a variety of utility, facility and process equipment.

    · Responsible for preparing and executing commissioning and qualification documents for a variety of utility, facility and process equipment. This includes FATs, URSs, DQs, SATs, CTPs, IQs, OQs, PQs, PVs and other validation life cycle document

    · Generate equipment/cleaning validation documents.

    · Develop validation and qualification protocols and reports for the Facility, Manufacturing Processes, Manufacturing Equipment, Packaging Equipment, Packaging Processes, Utilities and Cleaning verifications and validation for all equipment and products.

    · Develop/review requirements and specifications.

    · Able to follow-up and resolve comments, deviations, and technical issues.

    · Generate/execute variety of commissioning and qualification protocols for pharmaceutical equipment(IQ, OQ, PQ).

    · Must be able to work independently and in team environment.

    · Must be able to lead project with minimal supervision.

    · Coordinate the proper approval of plans, requirements, and protocols.

    · Review completed protocols for completeness, cGMP compliance and data acceptability.

    · Prepare validation summary and final reports.

    · Collaborates with various engineering system owners such as process, packaging, and automation to reduce product cost and increase productivity while sustaining or improving the validated systems.

    · Develop a strong documentation package, involving form conceptual study to various phases of projects like basic engineering, detail engineering, pre-commissioning / commissioning of equipment.

    · Qualification and documentation related to engineering department.

    · Conduct regular project review meetings within the team, with cross functional teams and with the vendors to control the project time to time.

    · Contribute to department efficiency initiatives


    · Bachelor's degree in relevant scientific discipline required

    · Equivalent experience will be considered


    · 3-7 years of experience

    · Hands-on experience in conceptual, detailed design, project planning, execution and qualification of biopharmaceutical facilities as per cGMP requirements.

    · Experience in developing Block Flow Diagrams, Process Flow Diagrams, Piping and instrumentation Diagrams, Mass and utility balances, safety analysis etc of biopharmaceutical processes.

    · Demonstrated experience with process valve matrix, process sequence logics, functional design specification (FDS), process control sequences, CIP/SIP sequences.

    · Experience reviewing/development of URS, Tendering, preparation of technical comparisons, DQ, FAT, SAT, commissioning, qualification and validation.

    · Excellent knowledge of pharmaceutical quality systems and Qualification practices.

    · Strong understanding of aseptic filling unit operations, controls, and drug product process validation is highly desired; a good understanding of resource forecasting is also highly desired.


    · Ability to work in a team structure; plan, organize and prioritize work.

    · Ability to analyze quantitative data, create and/or edit written reports and be able to process information.



    Company Description

    Prestigious media and broadcasting firm
    Posting ID: 601115206Posted: 2021-01-21