Validation Engineer

4 weeks ago

Westchester, United States Sterling Engineering Full time
Job Description

Job Overview:

The Validation Engineer will be responsible for the commissioning, validation, and qualification of equipment, facilities, and utilities within a pharmaceutical manufacturing environment. This role will be Temperature Mapping and updating old documentation to new standards for compliance purposes.

Responsibilities:

  • Write and Develop Equipment/Facility/Utility and Instrument Qualification protocols, as well as Validation/Qualification Policies.
  • Initiate Change Controls - provide validation assessments and remediation plans as required by the system/equipment/components.
  • 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, as well as adherence to ICH Q7.
  • Participate in Risk-Based evaluations, utilize Risk Assessment Methods/tools, and provide technical input during FMEA processes.
  • 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.
  • Validation/Qualification activities will cover - software, automated systems, laboratory instruments, production equipment, packaging systems, and facility utilities (HVAC, Water, etc.)
Preferred/Required Education/Skills:
  • Bachelor's or Master's degree in Engineering, Science, or a related field.
  • 3+ years of experience with commissioning, validation and qualification of Equipment/Facilities/Utilities and Processes using Risk Based approach and leverage strategies. Temperature mapping is a plus
  • Pharmaceutical, healthcare, or medical device industry experience is a plus


Qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or genetic information.

As one of the most respected names in engineering staffing, Sterling has hundreds of opportunities with top employers. If you've got a friend or colleague seeking their next move in engineering, we could have their next opportunity. We offer a referral bonus for every referral that we place. Submit referral now.

  • IT Support Engineer

    7 days ago

    Westchester, Illinois, United States Middleground Full time

    Middleground provides outsourced IT services to clients in the Chicago area, including industries such as Healthcare, Legal, Financial, Manufacturing, and many more. We are very fast paced and this position requires quick thinking and a "can do" attitude. We are looking for an eager, hungry, fast paced, and motivated local to Illinois individual for full...

  • IT Support Engineer

    4 weeks ago

    Westchester, United States Middleground Full time

    Job DescriptionJob DescriptionMiddleground provides outsourced IT services to clients in the Chicago area, including industries such as Healthcare, Legal, Financial, Manufacturing, and many more. We are very fast paced and this position requires quick thinking and a "can do" attitude.We are looking for an eager, hungry, fast paced, and motivated local to...

  • IT Support Engineer

    3 weeks ago

    Westchester, United States Middleground Full time

    Job DescriptionJob DescriptionMiddleground provides outsourced IT services to clients in the Chicago area, including industries such as Healthcare, Legal, Financial, Manufacturing, and many more. We are very fast paced and this position requires quick thinking and a "can do" attitude.We are looking for an eager, hungry, fast paced, and motivated local to...

  • IT Systems Administrator

    4 weeks ago

    Westchester, United States Middleground Full time

    Job DescriptionJob DescriptionWe are a rapidly growing IT Managed Service Provider located in the Westchester. We provide outsourced IT services to clients in the Chicago area, including industries such as Healthcare, Legal, Financial, Manufacturing, and many more. We are very fast paced and this position requires quick thinking and a "can do" attitude.The...

  • IT Systems Administrator

    3 weeks ago

    Westchester, United States Middleground Full time

    Job DescriptionJob DescriptionWe are a rapidly growing IT Managed Service Provider located in the Westchester. We provide outsourced IT services to clients in the Chicago area, including industries such as Healthcare, Legal, Financial, Manufacturing, and many more. We are very fast paced and this position requires quick thinking and a "can do" attitude.The...

  • Sr. Manager

    5 days ago

    Westchester, United States Ingredion Incorporated (Corporate) Full time

    The Sr. Manager - Artificial Intelligence/Machine Learning Technologies & Architecture will be responsible for managing, designing, developing, and deploying scalable and robust artificial intelligence and machine learning solutions for various business problems to enable digital transformation and innovation across various functions. This senior-level...

  • Sr. Manager

    3 days ago

    Westchester, United States Ingredion Incorporated Full time

    The Sr. Manager - Artificial Intelligence/Machine Learning Technologies & Architecture will be responsible for managing, designing, developing, and deploying scalable and robust artificial intelligence and machine learning solutions for various business problems to enable digital transformation and innovation across various functions. This senior-level role...

  • Sr. Manager

    17 hours ago

    Westchester, United States Ingredion Incorporated Full time

    The Sr. Manager - Artificial Intelligence/Machine Learning Technologies & Architecture will be responsible for managing, designing, developing, and deploying scalable and robust artificial intelligence and machine learning solutions for various business problems to enable digital transformation and innovation across various functions. This senior-level role...

  • Sr. Principal

    1 week ago

    Westchester, United States Ingredion Incorporated (Corporate) Full time

    Thank you for your interest in our Sr. Principal - Solution Architect - Innovation position here at Ingredion! We are currently hiring for this opportunity, but will be aiming to begin the hiring process in August. In the interim we encourage talented people such as yourself to always connect. Please complete the application and share your CV. When we begin...

  • Entry Level Solar Construction

    4 weeks ago

    Westchester County, NY, United States Venture Solar Full time

    **Venture Solar** is hiring a **Site Assessor.** **As a Site Assessor, you will be responsible for**: - Traveling to installation sites - Moving up to a 32' ladder from their truck to house for each site - Climbing ladders - Going in attics to get measurements - Measuring all roof facets - Structural inspection - Testing electric panel voltage -...

  • Entry Level Solar Construction

    3 days ago

    Westchester County, NY, United States Venture Solar Full time

    **Venture Solar** is hiring a **Site Assessor.** **As a Site Assessor, you will be responsible for**: - Traveling to installation sites - Moving up to a 32' ladder from their truck to house for each site - Climbing ladders - Going in attics to get measurements - Measuring all roof facets - Structural inspection - Testing electric panel voltage -...