Operations Engineer

Job Responsibilities

• Track, manage, and close out operational and engineering reliability projects and improvement initiatives.

• Lead or support efforts aimed at improving equipment and process reliability.

• Prepare and review documentation tied to process updates, change control, and quality-related actions.

• Ensure day-to-day operations remain compliant with U.S. and global regulatory expectations and applicable industry standards.

• Review validation activities for equipment, processes, and cleaning operations within assigned areas.

• Participate in internal audits and represent operations during external regulatory inspections.

• Serve as a quality point-of-contact for risk-based activities such as Failure Modes and Effects Analysis (FMEA).

• Investigate customer concerns, process deviations, and out-of-specification events using structured root cause analysis tools, ensuring accurate documentation and timely closure in the electronic quality management system.

• Gather, evaluate, and interpret batch and process data to identify trends, support compliance, and highlight improvement opportunities.

• Assist with drafting, updating, or revising procedures, batch documentation, and risk assessments in alignment with change management requirements.

• Respond quickly to operational issues in a fast-moving environment and support timely closure of deviation records ahead of product release.

• Work effectively with cross-functional partners, building strong communication pathways and positive collaboration.

Requirements

• Bachelor’s degree in engineering or a scientific discipline.

• Minimum of two years of relevant experience, ideally within pharmaceutical or sterile manufacturing environments.

• Hands-on experience performing detailed investigations using structured problem-solving tools (e.g., 5-Whys, fishbone diagrams, TapRoot, Kepner-Tregoe, comparative methods).

• Strong understanding of domestic and international regulatory expectations related to validation, documentation, and controlled manufacturing processes.

• Working knowledge of cGMP requirements and how they apply to aseptic production environments.

• Ability to collaborate across functions to resolve issues, address compliance gaps, and drive aligned outcomes.

• Familiarity with statistical tools and continuous improvement methodologies; Lean or Six Sigma certification is a plus.

• Strong organizational and project-management abilities, capable of working independently or as part of a team.

• Advanced proficiency in Microsoft Office applications, including Excel, PowerPoint, Word, SharePoint, and experience with MS Project or Visio.