Equipment Validation Engineer

Position: Equipment Validation Engineer

Location: Sanford, NC

Employment Type: Long Term Contract

About the Role:

·      We are seeking a highly skilled Equipment Validation Engineer to join our team.

·      The ideal candidate will be responsible for ensuring that all equipment and systems used in the production process are validated and comply with industry standards and regulatory requirements.

·      This role requires a strong background in equipment validation within the pharmaceutical or biotech industry.

Responsibilities:

·      Develop and implement validation protocols for new and existing equipment.

·      Perform equipment qualification and validation activities, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).

·      Create and maintain validation documentation, including protocols, reports, and risk assessments.

·      Collaborate with cross-functional teams including Quality Assurance, Regulatory Affairs, and Manufacturing to ensure compliance with regulatory requirements.

·      Conduct periodic reviews and revalidation of equipment as required.

·      Identify and resolve validation issues, implementing corrective and preventive actions (CAPA) as necessary.

·      Stay current with industry trends, regulatory requirements, and best practices related to equipment validation.

·      Participate in internal and external audits related to equipment validation activities.

·      Provide training and support to team members on validation protocols and procedures.

Qualifications:

·      Bachelor's degree in Engineering, Life Sciences, or a related field.

·      Proven experience as an Equipment Validation Engineer in the pharmaceutical or biotech industry.

·      Strong knowledge of GMP and regulatory requirements for equipment validation.

·      Excellent problem-solving skills and attention to detail.

·      Exceptional communication and interpersonal skills.

·      Ability to work collaboratively in a cross-functional team environment.

Preferred Skills:

·      Experience with computerized system validation (CSV).

·      Familiarity with validation software and tools.

·      Certification in validation engineering or a related field.

·      Experience with Lean or Six Sigma methodologies.