Job Description

BEPC is actively looking for a Senior Validation Engineer in San Angelo, TX area!

1 Year contract with possible extensions!

Benefits include medical, dental, vision, and life insurance

Our company is seeking a strong Validation Engineer to ensure that products and manufacturing processes meet regulatory requirements and industry standards. Have a strong understanding of quality control principles, risk management, and the ability to interpret and apply regulatory guidelines. Collaborate with cross-functional teams to address issues, troubleshoot problems, and ensure devices meet safety, reliability, and performance standards. Detail-oriented, analytical, and skilled in technical documentation and validation protocols.

Summary of Duties and Responsibilities:

• Strong knowledge and experience in generating equipment and fixture matrices for MVP, with qualification requirements defined by the medical device company.
• Create detailed and specific IQ/OQ validation protocols for medical device manufacturing and laboratory settings to client's requirements and standards.
• Execute detailed, technical IQ/OQ validation protocols for medical device manufacturing and laboratory settings, in line with client requirements and standards.
• Upon successful completion of IQ/OQ validations, author validation completion reports.
• Execute detailed and technical PQ validations as per client requirements and standards.
• Successful completion of PQ validations and author validation completion reports.
• Provide technical expertise and support to develop and implement all associated Standard Operating Procedures for newly validated medical device processes and laboratory equipment.
• Demonstrate experience in troubleshooting, root cause analysis, problem-solving, implementing effective corrective actions, and following GMP requirements to ensure compliance with all medical device regulations.
• Manage multiple complex validation projects on laboratory equipment simultaneously, from start to finish.
• Capable of handling all aspects of validation work, including the creation of IQ, OQ, and PQ documents.
• Perform other duties as required.

Qualifications:

• Bachelor’s Degree level in Science/Engineering field.
• Minimum 4+ years of experience as a Validation Engineer within a medical device, pharmaceutical, or similar regulated industry.
• Experience in aspects of Validation and ISO 13485 with proven knowledge of FDA and MDD GMP requirements regarding medical Devices or Pharma.
• Must be able to speak, comprehend, and write English.
• Effective verbal and written communication.

Preferred Qualifications:

• Validation methodology.
• GD&T and Statistical Engineering Qualification.
• Change documentation management using Adaptiv.
• Six Sigma Green/Black Belt trained/Certified

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