Senior Test & Validation Engineer

Manage the Process Validation activities required to comply with current regulations. Drafts, reviews, approve and facilitate completion of Process Validation protocols. Executes or manages execution of validation protocols and reports. Facilitates resolution of deficiencies that prevent successful validation of processes, conducts engineering testing, internal audits, equipment review, measurements, etc. Works closely with Engineering and Quality to ensure process validation plans are performed according to schedule.

This position can be worked remotely with an expected 50% travel requirement.

• Write process equipment validations, which would include (IQ, OQ, PQ) and the Final Report.
• Work closely with Engineering and Quality to complete the process validation of manufacturing equipment. This includes VMPs, URS, and other related documents to the Project Management Project process.
• Conduct DOE's, R&R, Capacity Studies, Sampling plans.
• Conduct PFMEA's.
• Coordinate Engineering, Quality and Manufacturing staff to support the required validation.
• Ensure that transfers of R & D projects meet equipment validation requirements.
• Initiate and evaluate all available technical data in order to develop conclusions derived from studies undertaken. Provide analysis, evaluation, and interpretation of data.
• Utilize appropriate project management skills and tools to meet timelines and provide progress updates to management.
• Periodically monitor existing validations and update/modify as conditions change.
• Other duties as assigned which may include process development, project management, process optimization projects or other duties to optimize the plant operations.

Required Experience:

• Bachelor's Degree in Engineering with a minimum 5-7 years of Process Validation experience or equivalent plant/process engineering experience that is demonstrated to add value to this position.
• Requires excellent interpersonal skills and strong team orientation.
• Requires excellent analytical, oral, and written communication skills.
• Proven record of facilitating project teams to achieve target goals and delivery timelines.

Preferred Experience:

• 3-5 years of experience in Quality and/or Regulatory
• 1-2 years of experience in Plant/Process Engineering

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