Senior Validation Engineer

4 weeks ago

Grand Haven, United States Barrington James 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

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