Sr. Plant Engineer

Role Summary

Use Your Power for Purpose. Our breakthroughs would not make it to the hands of patients without our pharmaceutical manufacturing team. As a Sr. Plant Engineer, your contributions will directly support the safe, efficient, and compliant operation of our manufacturing facilities.

Responsibilities

• Collaborate closely with manufacturing personnel and other departments to identify and resolve production issues. You will analyze root causes, recommend solutions, and implement process improvements that enhance operational efficiency and product quality.
• Serve as a liaison between manufacturing and maintenance teams to ensure timely and effective resolution of corrective work. Your coordination will help streamline communication and expedite repairs.
• Support the implementation of process equipment upgrades and optimization efforts. You will evaluate existing systems, propose enhancements, and oversee the integration of new technologies.
• Lead capital projects for the procurement, installation, and integration of new equipment. You will manage project timelines, budgets, and stakeholder communications to ensure successful execution.
• Troubleshoot complex issues with process and laboratory equipment. Your technical expertise will be critical in diagnosing problems and restoring functionality.
• Gain a deep understanding of the site’s active pharmaceutical ingredient (API) manufacturing processes. You will lead Process Hazard Analysis (PHA) sessions, provide training on risk mitigation strategies, and conduct investigations to identify and address safety concerns.
• Apply your experience in risk assessment to develop and implement proactive strategies that minimize incidents and process deviations. You will use data-driven approaches to enhance equipment and process safety.
• Contribute to the successful completion of engineering projects by managing your time effectively and developing detailed plans for short-term activities.
• Provide engineering support to define scopes of work, develop project execution plans, and conduct engineering studies for equipment installation and modification.
• Ensure that PSM requirements are incorporated into the design and scope of all capital projects. You will collaborate with stakeholders to align safety standards with project goals.
• Offer technical and PSM support for the API production area, helping to maintain compliance and operational excellence.
• Review preventive and corrective maintenance work orders and analyze equipment maintenance history. You will use the computerized maintenance management system (CMMS) data to identify trends, improve work processes, and recommend meaningful performance metrics.
• Evaluate equipment condition, performance, and maintenance history to justify capital replacements. Your assessments will include risk analyses to determine redundancy and reliability.
• Manage technical documentation, including writing and reviewing procedures. You will assist in the development and revision of preventive maintenance plans.
• Lead and participate in Root Cause Failure Analysis (RCFA) investigations for equipment and systems. You will update reliability plans based on findings and implement corrective actions.
• Conduct comprehensive PHAs for both existing processes and new projects. Your facilitation skills will ensure thorough risk assessments and actionable outcomes.
• Partner with production and quality team leads to troubleshoot issues and coordinate schedules. Your collaboration will support timely resolution and continuous improvement.
• Perform PSM self-audits and identify opportunities to enhance regulatory inspection readiness. You will develop action plans and track progress to ensure compliance.
• Actively engage in site and corporate initiatives such as Net Zero, Communities of Practice, and Limited Duration Teams. Your participation will contribute to broader organizational goals.
• Facilitate and participate in investigation teams addressing exemption reports, quality assurance reports (QARs), and laboratory investigations. You will serve as a liaison between quality, operations, and compliance to ensure timely and effective closures.
• Lead PSM incident investigations and collaborate with production teams to identify and implement corrective and preventive actions.
• Identify and develop initiatives to improve the productivity and effectiveness of engineering and PSM programs. You will leverage best practices and innovative solutions to drive performance.

Qualifications

• Required: A bachelor’s degree with at least 2 years of experience; OR a master’s degree with more than 0+ years of experience; OR an associate’s degree with 6 years of experience; OR a high school diploma (or equivalent) and 8 years of relevant experience in Electrical Engineering, Chemical Engineering, Mechanical Engineering, or equivalent science or engineering related discipline.
• Required: Demonstrated experience in assessing risks and implementing proactive strategies to minimize equipment reliability and PSM risks, as well as process deviations.
• Required: Proven ability to analyze equipment failures using personal expertise and available internal and external resources.
• Required: Strong project management skills, with a process-oriented mindset and the ability to develop and execute action plans aligned with organizational objectives.
• Required: Initiative, leadership, and excellent organizational, planning, interpersonal, and problem-solving skills.
• Required: Ability to influence and engage with multiple levels of the organization and lead cross-functional teams effectively.
• Preferred: Direct experience in project management within a biopharmaceutical or pharmaceutical cGMP environment.
• Preferred: Familiarity with FDA and OSHA PSM inspections and regulatory requirements.
• Preferred: Experience in facilitating PHAs and formal training in risk assessment methodologies.
• Preferred: Working knowledge of Lean, Six Sigma, and continuous improvement principles.

Additional Requirements

• Physical/Mental Requirements: Ability to perform complex mathematical calculations and data analysis; self-driven and insightful with strong decision-making capabilities; willingness to work in both office and field environments, including operating units; ability to wear personal protective equipment (PPE) and adhere to safety protocols.
• Work Environment: Typically, in an office environment, but must be willing to work in the field and operating units as needed to fully analyze situations and implement solutions.
• Non-standard Work Schedule / Travel: Standard work schedule, Monday – Friday, days; may infrequently require off-shift and weekend support.