Operations Engineer

Associate Director I Therapeutics I Head of DE&I at Skills Alliance Essential Functions

• Manage and track reliability‑related improvement initiatives across operations and engineering.
• Lead or support projects focused on reliability and process enhancement.
• Prepare, review, and approve change control and quality documentation for product or process changes.
• Ensure operational compliance with applicable U.S. and international regulatory standards and guidelines (e.g., FDA, EU, ISO, cGMP, etc.).
• Review validation protocols and reports (equipment, cleaning, and/or process) for assigned areas.
• Participate in internal and external audits and regulatory inspections.
• Serve as the quality contact for risk management activities, including FMEAs (Failure Modes and Effects Analyses).
• Investigate product deviations, out‑of‑specification results, and customer complaints to identify root causes and implement effective corrective and preventive actions.
• Analyze and report process and batch data to ensure compliance and identify areas for improvement.
• Develop, review, and revise Standard Operating Procedures (SOPs), batch records, and training materials in accordance with change management requirements.
• Adapt quickly to changing priorities in a fast‑paced, regulated environment.
• Work collaboratively across cross‑functional teams to identify and resolve issues efficiently.

• Bachelor’s degree in Life Sciences or Engineering (or related field).
• Minimum of 2 years of relevant experience in a regulated manufacturing environment; experience in pharmaceuticals, biotechnology, or medical devices preferred.
• Proven experience investigating deviations and implementing root cause analysis (RCA) using quality engineering tools such as 5‑Whys, Fishbone diagrams, Tap Root, or Kepner‑Tregoe.
• Strong understanding of applicable regulatory guidelines and validation principles for equipment, processes, and systems.
• Working knowledge of cGMP standards and quality management systems.
• Experience with statistical analysis tools;
  Lean or Six Sigma certification preferred.
• Excellent project management, problem‑solving, and organizational skills.
• Proficiency with Microsoft Office applications (Excel, PowerPoint, Word, SharePoint) and familiarity with MS Project and Visio.

Seniority level:
Associate

Employment type:

Full‑time

Job function:
Quality Assurance

Industries:
Pharmaceutical Manufacturing and Biotechnology Research