DUTIES & RESPONSIBILITIES

• Lead and execute thorough investigations for deviations related to equipment, utilities, facilities, maintenance, and engineering processes, ensuring accurate root–cause identification and implementation of effective corrective and preventive actions (CAPAs) to maintain regulatory compliance, product quality, and safety.

• Support activities to optimize the compliance state of the Engineering Department, including execution of quality records, monitoring quality systems and compliance KPIs, and coordinating audit programs.

• Adhere to all security, environmental health & safety regulations, and current Good Manufacturing Practices (cGMP) required for the role.

Key Responsibilities:

• Lead cross–functional investigations for manufacturing equipment and utility failures, environmental excursions, pest control, maintenance systems, human error, and other quality events.

• Apply structured problem–solving tools (e.g., 5 Whys, Fishbone Diagram, Fault Tree Analysis) to determine true root causes.

• Collaborate with Manufacturing, Quality Control, Engineering, and other departments to gather data and insights.

• Draft clear, concise, and scientifically sound investigation reports in compliance with cGMP and regulatory standards.

• Negotiate, recommend, and track CAPAs to ensure timely and effective implementation.

• Participate in continuous improvement initiatives to reduce recurring deviations and enhance engineering processes.

• Support pre–inspection requests, site regulatory inspections, and audit walkthroughs; complete responses for audit findings.

• Revise SOPs and lead or participate in improvement initiatives within the Engineering Department.

• Complete quality records (CAPAs, Standalone Actions, Effectiveness Checks) on time.

• Lead change controls: present to local review boards and act as change control owner through implementation.

• Maintain compliance metrics for the Engineering Department and contribute to trend analysis and reporting.

• Collaborate with reliability teams to assess equipment performance in parenteral manufacturing processes.

• Serve as subject matter expert on investigation and compliance topics; provide consults on quality systems and compliance matters.

• Support periodic review of department procedures and site qualification/validation of equipment and systems.

• Prepare technical documents (assessments, protocols, qualification reports) in accordance with corporate guidelines and regulations.

• Identify and escalate risks related to quality record extensions; support initiatives to minimize extensions.

• Plan and implement quality and productivity initiatives for equipment and utilities based on business priorities.

• Ensure compliance with corporate guidelines and site procedures governing operations.

• Maintain documentation in line with cGMP and FDA regulations.

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MINIMUM REQUIREMENTS

• Bachelor’s degree in science or engineering.

• Five (5) years of experience in the pharmaceutical or biotechnology industry, with emphasis on root cause analysis investigations and quality systems.

• Strong technical knowledge of manufacturing processes, processing equipment, and utilities for parenteral manufacturing.

• Proficient understanding of engineering disciplines (equipment/utilities, facilities, projects, maintenance systems).

• Proven ability to influence and collaborate with stakeholders at all levels; assertive communication and strong presentation skills.

• Technical writing proficiency and ability to manage multiple projects with minimal supervision.

• Strong project management, time management, planning, and organizational skills.

• Demonstrated leadership, teamwork, and relationship–building abilities.

**Weil Group is proud to be an Equal Employment Opportunity Employer.*