Company Overview
Pfanstiehl, founded in 1919, is a global leader in High Purity Carbohydrates for Biologics and has over 50 years of experience in custom synthesis and process development with a specialty in carbohydrates, amino acids, nucleosides and high potency APIs. Pfanstiehl’s customers include most of the world’s leading biopharmaceutical, vaccine and pharmaceutical companies and its products are utilized in market leading drugs that treat life threatening and debilitating diseases including cancer, COVID 19, rheumatoid arthritis, STDs, and diabetes. Increasing regulatory and quality requirement are benefiting biopharmaceutical and pharmaceutical suppliers like Pfanstiehl with high purity, strong cGMP controls and a strong reputation with FDA and other regulatory agencies.
Pfanstiehl is the premier manufacturer of cGMP high purity and low endotoxin injectable carbohydrate excipients (“High Purity Ingredients” or “HPIs”) utilized in the formulation and manufacturing of biopharmaceutical drugs and therapies. In addition, the Company specializes in the isolation, purification, custom synthesis, and scale-up development of small molecule Active Pharmaceutical Ingredients (API) and High Potency Active Pharmaceutical Ingredients (HPAPI) in gram to multi-ton commercial quantities.
Pfanstiehl has embarked on a long-term growth and investment plan to be a global HPI/HPAPI leader.
JOB SUMMARY
The primary role of the Reliability Engineer is to provide and/or improve asset reliability through utilization of Predictive Maintenance Technologies while keeping safety awareness a top priority.
The Reliability Engineer ensures that Pfanstiehl’s systems and equipment all perform dependably throughout their lifecycle by analyzing risks, preventing failures, and reducing breakdowns and downtime.
This position requires a motivated, self-starting individual who can collaboratively work across departments, including QA, Engineering, Maintenance, Purchasing, and Operations to build reliability into designs, engineered solutions, operative practices and shared analysis in order to achieve and sustain improved performance and reduced downtime and lower costs.
The Reliability Engineer will be required to identify, manage asset reliability risks that could adversely affect Production through analysis of data collected and risk assessments, he/she will make recommendations based on the health of the equipment tested. To include a risk management plan that will anticipate reliability-related and non-reliability-related risks that could adversely impact plant operations.
ESSENTIAL DUTIES AND RESPONSIBILITIES
Reliability Engineer Intern role requires assisting with the following:
Critical Systems Health- Heartbeat and Vital Signs
· Designing, maintaining, and managing a daily systematic focus; effectively monitoring and responding to the healthy ‘heartbeat’ needs of the Pfanstiehl Production Plant/Facilities.
· Create and utilize ‘vital signs’ for: Cleanrooms, DP pressures, Nitrogen, Environmental Monitoring Test Results, RO Water, Win 911 and Wastewater usage.
· Providing ‘vital signs’ weekly reports to VP Operations.
· Providing weekly Preventive Maintenance (PM) reports to VP Operations and Engineering
Parts Inventory-Critical Spares
· Designing the required parts inventory and ‘critical’ spares on hand for all critical pieces of equipment (centrifuges, Ultra filter, Water systems, Reactors & Dryers) Provide parts list to Purchasing.
· Facilitate the location and joint administration of the parts inventory with Purchasing, Engineering, Production. Records to be up-to-date, parts on hand.
· Lead Responsible Conduct of Research (RCR)- ‘breakdowns’ investigations. Provide root cause(s), and preventive measures (PM’s) to implement. Provide QA with reports for their review.
Work with Production
- Works with Production to perform analyses of assets including:
- Asset utilization
- Overall equipment effectiveness
- Remaining useful life
- Understands operations, procedures, inventory parts, LOTO, improvements, PM's, 5S, etc. within the production area.
- Other parameters that define operating condition, reliability, and costs of assets.
Work with Engineering
Develops engineering solutions to repetitive failures and all other problems that adversely affect plant operations. These problems include capacity, quality, cost, or regulatory compliance issues. To fulfill this responsibility, the reliability engineer applies:
- Data analysis techniques that can include:
- Statistical process control
- Reliability modeling and prediction
- Fault tree analysis
- Weibull analysis
- Six Sigma (6σ) methodology
- Root cause analysis (RCA) and root cause failure analysis (RCFA)
- Failure reporting, analysis, and corrective action system (FRACAS)
- Develops engineering solutions to repetitive failures based on root cause analysis.
Work with Project Engineering
- Works with project engineering to ensure the reliability and maintainability of new and modified installations. The reliability engineer is responsible for adhering to the life cycle asset management (LCAM) process throughout the entire life cycle of new assets.
- Participates in the development of design and installation specifications along with commissioning plans. Participates in the development of criteria for and evaluation of equipment and technical MRO suppliers and technical maintenance service providers. Develops acceptance tests and inspection criteria.
- Participates in the final check-out of new installations. This includes factory and site acceptance testing that will assure adherence to functional specifications.
Work with Maintenance
- Orders materials and services with the agreement of the Maintenance Supervisor and Manager
- Assist Maintenance Manager in communicating and negotiating with Senior Leadership Team (SLT) regarding critical maintenance issues.
- · Develops CMMS PM tasks for the preventative maintenance of mechanical, electrical, heating, Steam Boiler, Reverse Osmosis, ventilation, air conditioning, plumbing and refrigeration control systems.
Asset Maintenance Plan
- Professionally and systematically defines, designs, develops, monitors, and refines an asset maintenance plan that includes:
- Value-added preventive maintenance tasks
GENERAL
- Operate in accordance and compliance with:
- Current cGMP regulations and ICH Q7 guidelines
- Work Rules, Quality Policies (QP), and Standard Operating Procedures (SOP)
- Cardinal Rules of Quality, Delivery and Safety
- Other duties as assigned
QUALIFICATIONS
- Currently pursuing or recently completed a Bachelor’s degree in Chemical or Mechanical Engineering or related field.
- Exposure to maintenance reliability experience in a food, beverage, or pharmaceutical environment.
- Six sigma green belt or black belt (preferred).
KNOWLEDGE & SKILLS
- Working knowledge of risk management techniques such as PHA, FMEA, FTA, etc.
- Working knowledge and understanding of the Computerized Maintenance Management System (CMMS)
- Working knowledge of maintenance requirements in a cGMP environment.
- Strong communication and interpersonal skills
- Must be customer service oriented
- Ability to evaluate issues objectively, fairly, and consistently
- Ability to understand and follow directions as given
- Ability to work with minimal supervision
- Proficient in the use of standard Microsoft software packages, AutoCAD & Share Point
- Use miscellaneous office equipment (e.g., calculators, computers, FAX machines, copiers, etc.)
OTHER REQUIREMENTS
- Ability to meet or exceed the company’s attendance and punctuality standards.
- Ability to read, write, speak, and understand English fluently.
- Must be able to wear personal protective equipment
- Must be able to respond to visual and audible alarms
- Must be able to establish and maintain cooperative and effective working relationships with others
PHYSICAL REQUIREMENTS
- Must have good hearing and sight – adequate for safety programs in a pharmaceutical manufacturing plant
- Must be able to sit and/or stand for extended periods
- Frequent sitting, standing, walking, climbing of stairs, use of computer monitor screen, talking, writing, listening
- Must be able to lift 35 lbs.
- Ability to wear proper safety equipment when working in the laboratory or plant
- Physical ability to regularly work around and on industrial equipment, including frequent climbing of stairs and ladders, walking, climbing, bending, kneeling, lift, crouch or squat, twist, stooping and standing.
To perform this job successfully, an individual must be able to perform each duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
This job description reflects the general duties of the job but is not a detailed description of all duties which may be inherent to this position. Pfanstiehl may assign additional duties to individual employees, consistent with company policy.
Pay: $22.00 - $22.50 per hour
Application Question(s):
- Must be vaccinated for Covid-19.
Language:
Work Location: In person
