Quality Engineer - LATITUDE : Job Details

Salary: $75,000 - 85,000/yearThe Pharmaceutical QA Engineer will be responsible for ensuring the effective calibration, validation, and qualification of equipment used in the biopharma manufacturing process. This role is crucial in maintaining compliance with regulatory standards such as FDA, EMA, and cGMP, ensuring that all equipment meets performance specifications and operates within defined parameters.Responsibilities

• Lead the development, implementation, and execution of calibration programs for critical manufacturing equipment and systems.
• Conduct equipment validation and qualification (IQ/OQ/PQ) in accordance with cGMP, FDA, and other regulatory requirements.
• Ensure that all equipment meets safety, quality, and operational standards before production use.
• Prepare, review, and maintain validation and calibration documentation, including protocols, reports, and deviations.
• Ensure all activities comply with internal procedures, industry standards, and regulatory requirements.
• Support the creation and review of SOPs (Standard Operating Procedures) related to equipment calibration and qualification.
• Conduct internal audits and inspections to assess compliance with regulatory requirements and company policies.
• Investigate deviations and non-conformances related to equipment calibration and validation.
• Participate in risk assessments and assist in the development of CAPAs (Corrective and Preventive Actions) for any identified equipment issues.
• Work closely with cross-functional teams (engineering, manufacturing, regulatory, and R&D) to support equipment lifecycle management.
• Support training programs for staff on equipment calibration, validation processes, and quality standards.
• Provide expertise and troubleshooting support for ongoing equipment operations and improvement initiatives.
• Identify opportunities for process improvements related to calibration and validation activities.
• Stay up-to-date with industry best practices, regulations, and new technologies related to equipment qualification.

Requirements

• Bachelor's degree in Pharmaceutical Sciences, Engineering, Biochemistry, or a related field.
• Advanced degree (Master's or PhD) is a plus.
• Minimum of 1 year of experience in Quality Assurance, Calibration, and Validation within a pharmaceutical, biopharma, or related manufacturing environment.
• Solid knowledge of cGMP, FDA regulations, and global quality standards.
• Experience with equipment qualification and validation protocols (IQ/OQ/PQ).

$75,000 - $85,000 a year