Senior Validation Engineer

2 weeks ago

Grand Haven, United States CareerBuilder Full time

Senior Validation Engineer - Isolators
Grand Rapids, MI
6 Month, w2 contract with possible extensions

Barrington James Recruitment has partnered with an established consulting firm specializing in regulatory compliance services, particularly in industries such as pharmaceuticals, biotechnology, medical devices, and healthcare. They assist clients in navigating complex regulatory requirements and ensuring compliance with applicable laws and regulations.

The Sr. Validation Engineer supports validation of cGMP equipment, facilities and processes. These duties will include validation of production equipment, manufacturing processes, and utilities.

Responsibilities
Prepare appropriate documentation for assigned projects in the areas of equipment, software, process, control system, and critical system C&Q and validation activities.
Conduct validation studies.
Utilize risk assessment to identify critical areas for validation and generate test scripts accordingly.
Write, review and approve validation protocols/reports, change control documents, work orders, non-conformance reports, and document change requests.
Proactively and regularly communicate with the project team to update on validation status.
Identify process improvement opportunities and equipment needs for manufacturing.
Establish and maintain good practices with regards to processes and/or internal conditions leading to an aseptic environment.

Required
Completion of a bachelor's degree in Engineering is required for the Engineer role. Completion of a bachelor's degree in life sciences or related field is required for the Specialist role.
A minimum of 5 years related work experience in a pharma, biopharma, and/or biotech manufacturing environment.
Knowledge of cGMPs and Validation for API facilities, pharmaceutical manufacturing processes, clean rooms, utility systems, and packaging operations.
Previous experience validating isolators and autoclaves
Proficient computer skills in Microsoft Word, Excel, and Outlook.
Must be open to working in a 24/7 manufacturing environment.

Preferred
Knowledge of GAMP5, ISPE Baseline Guides for Commissioning and Qualification, and Annex 1 and FDA process validation guidance preferred

#LI-MA1

#J-18808-Ljbffr

  • Senior Validation Engineer

    Found in: Appcast Linkedin GBL C2 - 3 weeks ago

    Grand Haven, United States Barrington James Full time

    Senior Validation Engineer - IsolatorsGrand Rapids, MI 6 Month, w2 contract with possible extensions Barrington James Recruitment has partnered with an established consulting firm specializing in regulatory compliance services, particularly in industries such as pharmaceuticals, biotechnology, medical devices, and healthcare. They assist clients in...

  • Senior Validation Engineer

    Found in: Appcast US C2 - 3 weeks ago

    Grand Haven, United States Barrington James Full time

    Senior Validation Engineer - IsolatorsGrand Rapids, MI 6 Month, w2 contract with possible extensions Barrington James Recruitment has partnered with an established consulting firm specializing in regulatory compliance services, particularly in industries such as pharmaceuticals, biotechnology, medical devices, and healthcare. They assist clients in...

  • Senior Validation Engineer

    3 weeks ago

    Grand Haven, United States Barrington James Full time

    Senior Validation Engineer - IsolatorsGrand Rapids, MI 6 Month, w2 contract with possible extensions Barrington James Recruitment has partnered with an established consulting firm specializing in regulatory compliance services, particularly in industries such as pharmaceuticals, biotechnology, medical devices, and healthcare. They assist clients in...

  • Manufacturing validation engineer

    7 days ago

    North Haven, United States Katalyst Healthcares and Life Sciences Full time

    Responsibilities: Process and equipment qualification (IQ/OQ/PQ). Development of test methods for Design V&V, Process Validation, and Production. Validation of test methods. Execution of Engineering Builds, Gauge R&R Studies, Attribute Analysis Studies, and other validation work. uthoring/releasing of new test methods and editing/redlining of old test...

  • Senior Project Engineer

    3 weeks ago

    Grand Rapids, United States KLM Careers Full time

    Job DescriptionJob DescriptionSenior Project EngineerGrand Rapids, MI Must be a US Citizen or Green Card holder.A growing contract manufacturer in the medical device industry is seeking a Senior Project Engineer to join its team. In this role you will lead and provide technical support for a variety of projects supporting both new product development and...

  • Senior Project Engineer

    1 day ago

    Grand Rapids, United States Specialized Recruiting Group Full time

    A growing contract manufacturer in the medical device industry is seeking a Senior Project Engineer to join its team. In this role you will lead and provide technical support for a variety of projects supporting both new product development and existing product modifications, working with both internal and external customers to create project quote,...

  • Senior Project Engineer

    1 week ago

    Grand Rapids, United States Specialized Recruiting Group Full time

    A growing contract manufacturer in the medical device industry is seeking a Senior Project Engineer to join its team. In this role you will lead and provide technical support for a variety of projects supporting both new product development and existing product modifications, working with both internal and external customers to create project quote,...

  • Senior Project Engineer

    2 weeks ago

    Grand Rapids, United States Specialized Recruiting Group Full time

    A growing contract manufacturer in the medical device industry is seeking a Senior Project Engineer to join its team. In this role you will lead and provide technical support for a variety of projects supporting both new product development and existing product modifications, working with both internal and external customers to create project quote,...

  • Senior Project Engineer

    2 weeks ago

    Grand Rapids, United States CareerBuilder Full time

    Senior Project Engineer Grand Rapids, MI Must be a US Citizen or Green Card holder. A growing contract manufacturer in the medical device industry is seeking a Senior Project Engineer to join its team. In this role you will lead and provide technical support for a variety of projects supporting both new product development and existing product modifications,...

  • Field Engineer

    3 days ago

    Grand Haven, United States M.J. Electric Full time

    Position Purpose:This position serves as a primary technical resource and construction engineer for the successful completion of major industrial electrical construction projects.Responsibilities:Working with other project team members, review, understand, and administer contract requirements with a primary emphasis on the management of construction...

  • Senior Manufacturing Engineer

    Found in: Appcast Linkedin GBL C2 - 1 day ago

    Grand Rapids, United States Sira Consulting, an Inc 5000 company Full time

    Medical device equipment manufacturing, senior candidate • Experience working with equipment suppliers• Experience in supporting machine builders with kick off and design• Experience with Semi-automated and automated equipment• Experience with process development in various different processing including but not limited too Joining technologies /...

  • Senior Manufacturing Engineer

    1 day ago

    Grand Rapids, United States Sira Consulting, an Inc 5000 company Full time

    Medical device equipment manufacturing, senior candidate • Experience working with equipment suppliers• Experience in supporting machine builders with kick off and design• Experience with Semi-automated and automated equipment• Experience with process development in various different processing including but not limited too Joining technologies /...

  • Senior Manufacturing Engineer

    Found in: Appcast US C2 - 2 days ago

    Grand Rapids, United States Sira Consulting, an Inc 5000 company Full time

    Medical device equipment manufacturing, senior candidate • Experience working with equipment suppliers• Experience in supporting machine builders with kick off and design• Experience with Semi-automated and automated equipment• Experience with process development in various different processing including but not limited too Joining technologies /...

  • Senior Project Engineer

    Found in: Resume Library US A2 - 2 weeks ago

    Grand Rapids, Michigan, United States KLM Careers Full time

    Senior Project Engineer Grand Rapids, MI Must be a US Citizen or Green Card holder. A growing contract manufacturer in the medical device industry is seeking a Senior Project Engineer to join its team. In this role you will lead and provide technical support for a variety of projects...

  • Senior Test Engineer

    Found in: Appcast US C2 - 2 weeks ago

    North Haven, United States LanceSoft, Inc. Full time

    NO C2C Candidates, ONLY W2 Candidates pleaseBroad understanding of software validation techniques for medical or other regulated systems, you will develop a strong understanding of the SW architecture, design, and execute the test strategy, perform release activities of Software tests in compliance with regulatory standards.Bachelor’s Degree required with...

  • Senior Test Engineer

    Found in: Appcast Linkedin GBL C2 - 3 weeks ago

    North Haven, United States LanceSoft, Inc. Full time

    NO C2C Candidates, ONLY W2 Candidates pleaseBroad understanding of software validation techniques for medical or other regulated systems, you will develop a strong understanding of the SW architecture, design, and execute the test strategy, perform release activities of Software tests in compliance with regulatory standards.Bachelor’s Degree required with...

  • Senior Construction Engineer

    1 day ago

    Grand Rapids, United States Fishbeck, Thompson, Carr & Huber, Inc. (FTCH) Full time

    Position: Senior Construction Engineer Location: Grand Rapids, MI Job Id: 1782 # of Openings: 1 Senior Construction Engineer Location Grand Rapids, MI Job Summary Fishbeck is pursuing a full-time Senior Construction Engineer to...

  • Senior Civil Engineer

    2 weeks ago

    Grand Rapids, United States Comprehensive Engineering PC Full time

    Job DescriptionJob DescriptionWe are seeking a candidate to fill the position of Senior Civil Engineer.  This will be a key position in our firm, which requires civil site engineering skills along with communication and interpersonal skills necessary to work with clients.  The ideal candidate would have the desire to build and lead a civil department to...

  • Senior Civil Engineer

    4 days ago

    Grand Rapids, United States Comprehensive Engineering PC Full time

    Job DescriptionJob DescriptionWe are seeking a candidate to fill the position of Senior Civil Engineer.  This will be a key position in our firm, which requires civil site engineering skills along with communication and interpersonal skills necessary to work with clients.  The ideal candidate would have the desire to build and lead a civil department to...

  • Senior Civil Engineer

    2 weeks ago

    Grand Rapids, United States Comprehensive Engineering Full time

    Job DescriptionJob Description We are seeking a candidate to fill the position of Senior Civil Engineer. This will be a key position in our firm, which requires civil site engineering skills along with communication and interpersonal skills necessary to work with clients. The ideal candidate would have the desire to build and lead a civil department to...