QA Validation Engineer II: Quality & Validation Lead

Weil Group, Inc; Barceloneta (PR); On-site; USD 75,000 - 110,000; Full time

Job summary

Weil Group, Inc. is seeking a QA Validation Analyst/Engineer to plan, approve, and potentially execute validation activities. Under the Validation Section Manager, the role supports the Validation quality program at the plant with minimal supervision.

The position may involve reviewing commissioning and validation docs, leading investigations, and implementing preventive and corrective actions while supporting plant quality systems and regulatory audits.

Qualifications

• Experience with validation activities and quality systems.

Responsibilities

• Participate in the implementation and maintenance of the Quality System to meet regulatory requirements.
• Ensure practices and procedures comply with company policies and applicable regulations for Quality areas.
• Execute tasks to implement the Validation Master Plan and maintain validated state of equipment, utilities, facilities, and processes.
• Ensure investigations of validation failures are thorough, documented, and linked to CAPA as required.
• Participate with plant/external resources on new installations to ensure documentation complies with cGMP and supports validation.
• May supervise contract validation resources to timely complete activities in the area.

Job description

Weil Group, Inc. is seeking a QA Validation Analyst/Engineer to plan, approve, and potentially execute validation activities. Under the Validation Section Manager, the role supports the Validation quality program at the plant with minimal supervision.

The position may involve reviewing commissioning and validation docs, leading investigations, and implementing preventive and corrective actions while supporting plant quality systems and regulatory audits.