Mechanical (Maintenance) Engineering Consultant
Compli

Compli, LLC was founded in 2001 to provide Commissioning, Validation and Regulatory Support Services to the Life Sciences industry.

We serve pharmaceutical companies across the United States, offering a vast array of services that assist companies with exceeding their goals and objectives. In today•s world, it•s never been more important to understand regulations and quality assurance activities as they relate to operations, vendors, engineering, construction and contractors. In 2020, Compli, LLC became a wholly owned subsidiary of George Butler Associates, Inc. This acquisition allowed Compli, LLC to become part of an integrated network of services where clients have more options to engage an impressive suite of in-house services.

Responsibilities:

• Identifies and leads or works with Reliability Engineering on site M&R initiatives including:
  • Supporting debugging and troubleshooting efforts around utilities and equipment
  • Support site M&R efforts
  • Prioritize the recommendations from the assessment and develop a mitigating timeline
  • Improving the level of equipment selection and equipment availability and uptime
  • Ensuring effective contractor management is occurring and proper installation procedures and specifications/tolerances are being adhered to
  • Accuracy, training, and use of the site Computerized Maintenance Management System (CMMS)
  • Drawing/Documents Management
  • Execution of Work Management Best Practices
  • Adoption of Maintenance Planning & Scheduling
  • Use of applicable Predictive Maintenance (PdM)/Condition Monitoring technologies
  • Review and optimization of the PM/PdM program
  • Perform Failure Modes & Effects Analysis, Reliability Centered Maintenance where required.
  • Support the site compliance efforts by the timely management of any deviations and investigations related to cGMP practices where applicable to your team
  • Support Maintenance Training program
• Supporting measuring and reporting departmental KPI•s
• Ensure the concept of working safely is well-communicated throughout the Maintenance team
• Support the Maintenance team to ensure they are achieving all identified goals and objectives

Qualifications:

• Possess a minimum of three (3) years performing maintenance/mechanical engineering related activities in the aseptic fill/finish pharmaceutical manufacturing (GMP) industries.
• Technical school or Engineering bachelor•s degree: Mechanical or Electrical Engineering is preferred, however, the equivalent combination of education/experience may be accepted in lieu of degree
• Proficiency in MS Office software (Excel, Outlook, PowerPoint)
• Familiarity with Pivot Tables and V-Look ups
• Proficient in the use of Maintenance CMMS or EAM systems like IBM Maximo, SAP PM/S4Hana, Oracle/JDE, eMaint, Mainsaver, etc.
• Excellent communication skills • written and verbal as well as negotiation tactics
• Ability to maintain effective working relationships and make effective decisions
• Ability to communicate effectively to the internal Maintenance staff as well as external vendors
• Possess a strong mechanical &/or electrical aptitude
• Ability to draft routine reports and correspondence with Senior Leadership
• Prefer at least one industry Certification as either a:
  • Certified Maintenance & Reliability Professional (CMRP)
  • Certified Reliability Leader (CRL)
  • Certified Maintenance Manager (CMM)

Travel:

• Must be willing to travel to support on-site project work within the U.S. Travel and Living expensed are reimbursed.

It•s more than just a job•

At Compli, we are about innovative and intelligent people who want to solve problems. We•re known for our technical excellence, but we bring so much more to the table. We strive to create remarkable solutions for a higher quality of life. And we are changing the industry by integrating the design and construction process with use of new technology.

At Compli, we are an Equal Employment Opportunity Employer promoting diversity in our workforce by including all individuals regardless of age, race, religion, color, sex, national origin, marital status, genetic information, sexual orientation, gender identity, gender expression, disability, veteran status, pregnancy status, or any other status protected by law.

---