Plant & Reliability Engineer

As a Plant & Reliability Engineer at Forge Biologics, you'll provide critical hands-on support for both GMP and non-GMP equipment and facilities. Your responsibilities will include operational support for client campaigns, developing preventive maintenance strategies, and ensuring compliance with quality standards. You'll actively participate in process hazard analyses and work with cross-functional teams to enhance asset health and reliability. Your role will be fundamental in supporting our overarching goal of enabling life-changing gene therapies.

To thrive as a Plant & Reliability Engineer at Forge Biologics, candidates should possess at least 4 years of experience in a similar role within a regulated manufacturing environment. A bachelor’s degree in Mechanical, Electrical, or Chemical Engineering is preferred. Familiarity with reliability-centered maintenance programs and predictive maintenance technologies is essential. Candidates should also have strong analytical skills and the ability to design and implement proactive maintenance strategies.

At Forge Biologics, we value the growth and development of our team members. As a Plant & Reliability Engineer, you'll have access to professional and personal development resources, including training programs tailored to enhance your technical skills and industry knowledge. Additionally, Forge offers robust benefits, including wellness initiatives and paid parental leave, ensuring our employees feel valued and supported in their career journeys.

The work environment for Plant & Reliability Engineers at Forge Biologics is both dynamic and collaborative. Situated in our spacious facility known as the Hearth, engineers engage in a blend of office work and hands-on engineering challenges. The facilities work environments may vary, with moderate to loud noise levels, and engineers must be prepared to navigate both sterile environments and typical office settings while adhering to safety protocols.

At Forge Biologics, we seek candidates for the Plant & Reliability Engineer position who are not only technically skilled but also embody our core values of hardworking, openness, purpose-driven engagement, and enthusiasm. We are looking for individuals who can clearly identify issues, develop robust technical solutions, and are passionate about contributing to the mission of manufacturing transformative gene therapies for patient care.

In discussing your experience with reliability engineering in regulated environments, focus on specific projects you’ve worked on and the methodologies implemented. Highlight your familiarity with regulations such as ISO or FDA and how your strategies improved compliance and efficiency. Share examples of how you have developed preventive maintenance plans that significantly reduced downtime.

When troubleshooting a frequently failing GMP asset, I would begin with a thorough root cause analysis, examining data logs, maintenance records, and operational procedures. Collaborating with team members across Production and Quality Assurance is essential to identify potential problems that may not be apparent in isolation. The goal would be to implement corrective actions that address the identified issues, enhancing the overall reliability of the asset.

To optimize preventive maintenance, I have utilized data analytics to determine the most effective maintenance schedules based on asset performance and failure histories. Employing a condition-based maintenance approach allows for more targeted interventions, reducing unnecessary maintenance tasks while keeping equipment in top operating condition. I emphasize the importance of training staff on these strategies to ensure everyone is aligned on best practices.

Ensuring compliance with safety and quality standards begins in the planning phase of any engineering project. I ensure that all stakeholders review and adhere to relevant SOPs and regulations. During project execution, I prioritize safety audits and quality checks at each milestone, actively seeking input from QA teams to remain within guidelines while fostering open communication among team members about compliance responsibilities.

When discussing a successful CapEx project, provide details on the project scope, budget, and challenges encountered. Explain how you organized the project flow, from conception through execution, and the outcome it had on operations. Highlight your collaboration with cross-functional teams, as it’s essential to align engineering goals with other departments’ needs to achieve project success.

My experience with FMEA involves leading analysis sessions for various equipment and processes. I meticulously assess potential failure points, their consequences, and likelihood, collaborating with diverse teams to ensure comprehensive coverage. By developing actionable mitigation strategies from these analyses, I strive to reduce risks proactively, contributing valuable insights to our continuous improvement processes.

In managing conflicts over project priorities, I believe in open and honest communication. I encourage team members to express their views and work collaboratively to find common ground. By focusing on data-driven analyses to inform decisions, we are able to align our objectives more effectively and ensure that everyone feels heard, fostering a commitment to the project’s success.

Data plays a crucial role in my reliability engineering approach. I utilize equipment analytics and performance metrics to identify trends, inform maintenance schedules, and anticipate issues before they arise. By actively leveraging data-driven insights, I enhance decision-making processes and strategy development to contribute to improved operational reliability and efficiency.

My experience with building automation systems (BAS) involves managing and monitoring HVAC, lighting, and security systems to ensure compliance with operational standards. I have worked extensively in configuring BAS to optimize energy usage and enhance the operational efficiency of facilities. My ability to interpret BAS data analytics allows for prompt responses to discrepancies in environmental controls.

I stay updated on industry trends and technologies in reliability engineering through continuous professional development, attending industry conferences, and engaging in relevant training workshops. Networking with industry experts and participating in online forums also aids in understanding emerging technologies that could enhance reliability engineering practices. I regularly read trade journals to stay informed on best practices and innovations.