Reliability Jobs in Noblesville in
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Director Engineering Facilities and Reliability
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Perpetual Labor SourcingNoblesville, IN, United StatesDirector Engineering Facilities and Reliability
Curium Live ForwardNoblesville, IN, United States30+ days ago
Job type
- Permanent
Job descriptionBachelor degree in Engineering or related field required. 15 or more years of relevant experience in cGMP manufacturing, equipment and / or facility maintenance experience in the biotechnology or pharmaceutical industry and / or prior industrial maintenance experience involving mechanical, electrical and electronics in a cGMP regulated environment 5 or more years in a leadership role required. Working knowledge of automation controls, alert and data collection / retention systems Working knowledge of HVAC and clean utility systems (process air and RO systems) Experience managing capital projects, including estimate development, capital justification and approval, schedule development / management, and execution. Experience in Total Productive Maintenance, condition monitoring and predictive maintenance. Experience ensuring cGMP compliance. Direct experience in generating and executing qualification of equipment and validation of processes. CMMS software experience. Proven ability to develop and implement vision and cultural changes. Experience in leading cross functional teams. Fiscal / budgetary responsibility. Experienced with formal Root Cause identification and correction. Must be self-managed, wholly responsible for department, committed to meeting deliverables and timelines with limited direction from supervisor. Must have excellent oral and written communication and presentation skills. Willingness to work in plant producing radioactive materials and requiring all employees to participate in safety programs designed to minimize potential and / or actual exposure levels. Responsibilities include the ability to lift up to 70 pounds, kneeling, crouching, twisting the upper body, walking, bending, stooping, pushing, pulling, reaching, must be able to physically negotiate stairs and evacuation ladders with or without accommodation, wear and operate safety equipment, enter vessels, and inspect equipment. Material handling devices (e.g., hand truck, fork truck, and conveyors) are used when possible, however, use of proper lifting and movement techniques is necessary to prevent injury. Must be willing to wear a variety of Personal Protective Equipment (PPE) and hearing protection as needed. May be required to sit or stand for long periods of 8+ hours a day while performing duties. Must possess good hand-eye coordination; close attention to detail is required. Must be able to work indoors and outdoors with exposure to mechanical / moving parts, hazards including corrosive, flammable and toxic material, dust, dirt, odors, and irritants. Willingness to complete safety training within allotted timeframes, and work in a team-based environment. Must be able to work outside of regular work hours, including off shift, weekend, and holiday work as business needs require.
Summary of Position
The Director Engineering serves a pivotal role in overseeing critical aspects of site operations, ensuring safety, compliance, and efficiency in a radioactive pharmaceutical facility. Responsibilities will encompass equipment and facilities maintenance, metrology, process engineering, facility engineering, automation, asset / project delivery, site CapEx program management, asset reliability and project management. The role will lead a team of skilled professionals and collaborate closely with cross-functional departments to drive excellence in engineering services, adhering to regulatory standards and guidance.
Work Schedule : Monday – Friday 8 : 00am – 5 : 00pm
Essential Functions
- Ensure that all equipment and facility and automation systems, meet current Good Manufacturing Practice (cGMP) requirements.
- Implement a risk-based approach to maintenance, conducting regular risk assessments to identify critical equipment and systems.
- Establish and maintain a robust reliability program to maximize equipment uptime.
- Monitor and control environmental conditions to meet aseptic manufacturing facilities requirements.
- Lead the Engineering team in designing, implementing, and validating control systems that comply with Process Validation regulations and guidance.
- Ensure that automation systems, including Programmable Logic Controllers (PLCs) and Human-Machine Interfaces (HMIs), adhere to regulations for electronic records and signatures.
- Develop and maintain a Change Control system in accordance with regulations / guidelines to manage changes to control systems.
- Collaborate with Validation and Quality Assurance teams to perform risk assessments and qualification / validation activities in line with US and international Process Validation guidance.
- Implement advanced process control strategies to optimize production processes including reducing process variability.
- Develop and maintain the Site’s capital plan aligned with the company's strategic objectives and Site Master Plan, and in accordance with US and international requirements for equipment qualification.
- Prepare detailed project proposals and justifications, considering cost-benefit analyses and ensuring compliance with US and international regulations.
- Utilize a robust Project Management system for project management and execution.
- Lead cross-functional project teams, including engineers, quality professionals, and regulatory experts, to ensure projects meet scope, schedule, and budget targets.
- Develop and manage the site controlled drawing program in accordance with regulatory guidance.
- Collaborate with the Regulatory Affairs team to prepare and submit regulatory filings and updates in compliance with US and international submission requirements.
- Conduct regular risk assessments to identify and mitigate potential risks associated with facility maintenance, control systems, and capital projects.
- Implement a Corrective and Preventive Action (CAPA) system in accordance with US and international regulations / guidelines.
- Collaborate closely with Research & Development to ensure seamless technology transfer of new pharmaceutical products.
- Engage with the Quality Assurance department to establish and maintain a robust Quality Management System (QMS).
- Partner with Production to optimize manufacturing processes, reducing waste and enhancing efficiency while ensuring product quality.
- Regularly communicate progress, challenges, and opportunities to senior leadership and participate in executive-level decision-making discussions.
- The multifaceted role of Director of Engineering Services is at the forefront of ensuring that the radioactive pharmaceutical facility not only meets but exceeds the regulatory expectations. Leadership, attention to detail, and commitment to safety and compliance will be critical in driving our mission of delivering high-quality pharmaceuticals while adhering to the highest ethical and regulatory standards.
- Must maintain operational compliance with US and international regulatory agencies and guidelines (i.e. FDA, EU, HC, TGA, PIC / S, ISO, USP, NRC, cGMP, etc.).
Requirements
Working Conditions :