Intellectt INC
Location
Mansfield, TX | United States
Job description
Job Title: Manufacturing Process Validation Engineer
Location: MA
LOA: 1 year
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Job Description:
Following post acquisition and FDA audits they were given a list of over 100 CAPA's. There are a list of improvements they would like addressed that will be applicable to multiple pieces of equipment. The improvements are not equipment specific in nature. CAPA's will be related to hands-on manufacturing process validation.
Project Scope:
This Engineer will have the opportunity to help with anything from being part of CAPA to owning a CAPA to revising SOP's depending on where their strengths lie/ what they are capable of handling.
For this role they are looking for someone with expertise in validation specifically . Many of the audit findings are regarding insufficient validation processes/ SOP's. They would like this engineer to come in and recommend new ways of testing things, more efficient validation processes/ SOP's etc...
Position Overview:
Client is seeking a highly skilled and experienced Senior Manufacturing Validation Engineer in MA. As a Senior Manufacturing Validation Engineer, you will play a crucial role in ensuring the quality, compliance, and efficiency of our manufacturing processes, specifically focusing on validation activities. You will work closely with cross-functional teams to develop and implement robust validation strategies and ensure compliance with regulatory requirements.
Responsibilities:
-Develop and execute validation strategies, protocols, and reports for manufacturing processes, equipment, and systems to ensure compliance with FDA, ISO, and other relevant regulatory standards.
-Lead and oversee the execution of validation activities, including process and equipment qualification, cleaning validation, and software validation.
-Collaborate with internal stakeholders, including R&D, Quality Assurance, and Operations, to ensure alignment on validation requirements and deliverables.
-Conduct risk assessments and apply statistical methods to evaluate process capability, identify areas for improvement, and drive process optimization initiatives.
-Lead investigations into process deviations and non-conformances, perform root cause analysis, and implement corrective and preventive actions (CAPAs) as necessary.
-Provide technical guidance and mentorship to junior engineers, supporting their professional growth and development.
-Stay updated with industry best practices, regulatory guidelines, and technological advancements relevant to manufacturing validation, and proactively incorporate them into the clients practices.
-Collaborate with cross-functional teams to support new product introductions and process transfers, ensuring robust validation plans are in place.
Requirements:
-Bachelor's degree in Engineering or related field; advanced degree preferred.
-Minimum of 7 years of experience in manufacturing validation within the medical device industry. Preferable heart pump/ catheter.
-Strong knowledge of FDA regulations, ISO standards (e.g., ISO 13485), and other relevant regulatory requirements.
-Experience with the validation of manufacturing processes, equipment, cleaning, and software systems.
-Proficiency in statistical analysis tools and techniques for process capability assessment and data analysis (e.g., Minitab).
-Proven track record of successfully leading and executing validation projects from start to finish.
Soft Skills:
-Excellent problem-solving skills and ability to conduct thorough root cause analysis.
-Strong communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams.
-Detail-oriented mindset with a focus on quality and compliance.
Plus:
-Prior experience in cardiovascular or medical device manufacturing is a plus (catheter devices is even better)
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