Reliability Engineer II

This position reports directly to the Vice president of Engineering. The role is responsible for overseeing management of the preventative and predictive maintenance of the manufacturing and facility equipment. Responsible for ensuring reliability – Mean Time Between Failure (MTBF) and maintainability – Mean Time to Repair (MTTR) of equipment, processes, utilities, facilities, controls, and safety/security systems. Manage asset reliability risks that could adversely affect business operations. Be responsible for ensuring the smooth operation and optimal performance of all equipment and machinery in the facility and developing and implementing effective predictive maintenance programs like OEE to reduce downtime. The position will also serve as the Blue Mountain Computerized Maintenance Management System (CMMS) Administrator and champion the use of the tool to improve equipment and facility performance.

Why Join Leiters Health?

Are you passionate about making a real impact in the pharmaceutical industry? Do you thrive in a collaborative, innovative environment where your skills and ideas are valued? Look no further – Leiters Health is seeking talented individuals like you to join our dynamic team!

At Leiters Health, we're not just another pharmaceutical company – we're pioneers in the field, dedicated to delivering high-quality compounded sterile products and outsourced solutions to healthcare providers nationwide. Our commitment to excellence and patient safety is at the core of everything we do.

• Innovative Culture: Be part of a forward-thinking company that encourages creativity, welcomes fresh ideas, and fosters an environment of continuous improvement.
• Meaningful Work: Contribute to a purpose-driven organization dedicated to providing critical medications and healthcare solutions that positively impact patients' lives.
• Professional Development: Access ongoing training, mentorship, and growth opportunities to expand your skills and advance your career within a rapidly growing industry.
• Cutting-Edge Technology: Work with state-of-the-art facilities and advanced technologies, staying ahead of the curve in pharmaceutical manufacturing.
• Collaborative Environment: Join a team of passionate individuals who are dedicated to teamwork, support, and mutual success, fostering a culture of inclusivity and collaboration.

Who We're Looking For:

We're seeking enthusiastic individuals who are driven, adaptable, and passionate about contributing to a mission-driven organization. Whether you're an experienced professional or just starting your career, Leiters Health provides an environment where your skills and talents will be recognized and appreciated. Sound like you? Apply today!

Essential Functions:

Responsible for the overall facilities management:

• To define, design, develop monitors and refine an asset maintenance plan that includes:
  1. Value-added preventive maintenance tasks.
  2. Effective utilization of predictive and other non-destructive testing methodologies designed to identify and isolate inherent reliability problems.
• Develops engineering solutions to resolve repetitive failures and all other problems that adversely affect plant operations. These problems include capacity, quality, cost, or regulatory compliance issues.
• Applies data analysis techniques that can include:
  1. Statistical process control
  2. Reliability modeling and prediction
  3. Root cause analysis (RCA) and root cause failure analysis (RCFA)
  4. Failure reporting, analysis, and corrective action system (FRACAS)
  5. Failure Modes and Effects Analysis (FMEA)
• Assists counterparts in Production, Maintenance, Technical Services, Quality and Engineering to perform analyses of assets including:
  1. Asset utilization
  2. Equipment Effectiveness
  3. Remaining useful life.
  4. other parameters that define operating conditions, reliability, and costs of assets.
• Applies value analysis to repair/replace, repair/design and make/buy decisions.
• Support technician development program so tech skill levels align with improved equipment reliability requirements. Encourage and facilitate the development of maintenance team members through the technician advancement program.
• Leverage maintenance resources to proactively identify opportunities and carry out projects to improve safety, productivity, cost, and quality. Manage projects and provide direction to contractors and vendors as required.
• Utilize computerized maintenance management systems (CMMS) to manage work.
• Ensure effective resolution of problems through timely failure analysis, identification of root cause of failures, and implementation of corrective actions to prevent recurrence.
• Improve and implement equipment and machinery maintenance programs (SOP) based on predictive maintenance principles to ensure the efficient operation of all equipment and machinery in the facility.
• Use data analysis to help prepare for and prevent future problems.
• Create and implement measures to minimize breakdowns and repairs (performing quality checks of all machinery, tools, equipment, etc.).
• Continuously monitor and evaluate maintenance operations, identifying opportunities for improvement and implementing solutions to optimize efficiency and reduce downtime.
• Mentor less experienced personnel.
• Create a work environment with safety as a high priority.
• Other duties as assigned

Experience & Necessary Skills:

• Bachelor’s degree in engineering or related field.
• 5+ years of experience in a predictive equipment maintenance management role, preferably working with Aseptic filling equipment, packaging equipment, visual inspection equipment, Utilities equipment and fully automated assembly machines.
• Proven track record of developing and implementing effective predictive maintenance programs.
• Strong knowledge of maintenance-leading practices, including preventative maintenance, predictive maintenance, and reliability-centered maintenance.
• Interface with Facilities Engineering, Capital Project Management, Quality Assurance, QC, Regulatory Compliance, EH&S, and Manufacturing.
• Knowledge of cGMP guidelines/standards and ISO Room Classifications.
• Knowledge of CMMS system, Blue Mountain preferred.
• Demonstrated written and oral communications skills including strong presentation skills.
• Ability to build consensus across manufacturing and functional teams.
• Aptitude to regularly and effectively present complex technical information/analysis and respond to questions from technical staff members and management.
• Understanding of and adherence to good manufacturing practices (GMP) and FDA regulations.
• Excellent organizational skills.
• Strong results orientation.
• Proficiency in Microsoft Office products including Outlook, Excel, Project and Word

Preferred Skills:

• Knowledge in Lean 6S & Six Sigma, Continuous cost reduction, OEE improvements, and Root Cause Analysis (RCA).
• Working knowledge of the BMS and EMS systems.
• Knowledge and experience in mechanical design and CAD, with SolidWorks experience preferred.

Physical requirements:

General physical requirements to successfully perform the essential job duties are: Ability to pass aseptic gowning qualification and occasional lifting up to 50 pounds.

Benefits:

• Smart healthcare coverage options that rewards wellness (and puts money back in your pocket!)
• Dental & Vision insurance options including FSA & HSA
• Employer Paid Life Insurance & Employee Assistance Program
• Short Term & Long-Term Disability Insurance
• Up to 4% 401K Matching (100% vested on day one!)
• Generous Paid Time Off Options – vacation, sick, paid leave and holidays!
• $5,250 Annual Tuition Reimbursement after 6 months
• $1,000 Referral Bonus Program with no limit
• Eligible for annual bonus program

Timeline : We will be accepting applications on an ongoing basis until position is filled.

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law.

*Please note that we do not work with third-party recruiters or agencies for this position. If you are a qualified candidate and wish to apply for this job, please do so directly through our official application process. We appreciate your understanding and cooperation in this matter.