• Validation Engineer III

    ThermoFisher Scientific (Allentown, PA)


    Work Schedule

     

    Standard (Mon-Fri)

     

    Environmental Conditions

     

    Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cold Room/Freezers -22degreesF/-6degrees C, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

    Job Description

    Location/Division Specific Information

     

    CTD partners with pharmaceutical and biotech customers around the world to ensure the right patients get the right therapies in the right doses at the right time – a concept that we internally embrace as “There is a Patient Waiting.” Our unique blend of services includes project management, packaging, distribution, transportation management and specialty logistics, ancillary supply management, clinical supply optimization, bio-repository storage and much more. Our more than 3,500 employees in over 15 countries work hard every day knowing that what they do matters.

     

    How will you make an impact?

     

    As part of our team, what you do contributes directly to our mission; enabling our customers to make the world healthier, cleaner and safer.

     

    What will you** **do?

     

    As a Validation Engineer III, you will be tasked with interacting with several departments to provide validation support for computer systems, equipment and processes, along with the critical utilities and facilities required for packaging operations at the site.

     

    Accountable for preparing and carrying out validation documentation (VP, IQ, OQ, PQ) along with producing the related summary reports

     

    Give to the preparation of Process Performance Qualification (PPQ) documentation, which includes Control Strategy, Product Knowledge assessment, Process Failure Modes and Effects Analysis, Validation Strategy, and PPQ Generate, complete, and review protocols for controlled temperature units (Freezers and Coldrooms) and packaging equipment.

     

    Perform risk assessment and mitigation supporting the attainment and maintenance of a validated state of compliance for all equipment, processes, materials, and facilities.

     

    Conduct all work according to governing SOPs and cGMPs (current Good Manufacturing Practices)

     

    Analyze the results of testing and resolve acceptability of results against pre-determined criteria.

     

    Identify protocol discrepancies from established product or process standards and provide recommendations for resolving them.

     

    Work closely with engineering to coordinate and complete Factory Acceptance Testing (FAT) activities and protocols.

     

    Prepare detailed reports or build statements based on results of validation and qualification tests or reviews of procedures and protocols

     

    Coordinate with other departments or outside contractors/vendors to complete validation tasks Assist with identification of Master Plan (VMP) as required Author SOPs (Standard Operating Procedures) and Validation Documentation within Documentum Conduct all activities in a safe and efficient manner

    Knowledge, Skills, Abilities

    + Knowledge of Computer System Validation (CSV)

    + Knowledge of Controlled Temperature Unit Operation and Management

    + PC literacy including the ability to generate sophisticated documents in both Microsoft Excel and Microsoft Word

    + Effective communication skills

    + Strong analytical skills

    + Ability to multitask and respond to shifting priorities

    + Effective written and verbal interaction abilities

    + Prior mechanical and process equipment experience

    Desired Qualifications

    Proficient with Mini-Tab or similar statistical analysis software

     

    Knowledge of pharmaceutical packaging materials and equipment

    Education

    + A four-year Bachelor of Science degree in Engineering or Science from an accredited college is required.

    + You must have 2-5 years of validation experience in a regulated industry or equivalent experience. This includes five years in food or pharmaceutical packaging or cGMP experience.

    Physical Requirements

    + Needs to be capable of lifting 35 pounds

     

    Benefits

     

    We offer competitive remuneration, annual incentive plan bonus scheme, healthcare, and a range of employee benefits! Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation.

     

    Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.