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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. Compli is full services Commissioning, Qualification, Regulatory Compliance and On Demand services firm.
Essential Functions
- Function as an owner’s representative and report to the client’s management lead.
- Coordinate internal and external resources for the flawless execution of projects.
- Ensure that all projects are delivered on time and within scope.
- Assist in the definition of project scope and objectives, involving all relevant stakeholders and ensuring technical feasibility.
- Develop a detailed project plan to monitor and track progress.
- Manage changes to the project scope, project schedule and project costs using appropriate verification techniques.
- Measure project performance using appropriate tools and techniques.
- Manage the relationship with the client and all stakeholders.
- Perform risk management assessments to minimize project risks.
- Establish and maintain relationships with third parties/vendors.
- Meet with clients and clarify specific requirements of each capital project.
- Track project performance, specifically to analyze the successful completion of short and long-term goals.
- Perform other related duties as assigned by the client’s representative.
Education & Experience
- Bachelor’s degree in an engineering field; preferably mechanical engineering or construction management.
- At least seven (7) years of pharmaceutical engineering and capital project management experience.
- Must be familiar with aseptic manufacturing processes and the specifying of aseptic processing equipment.
- PMP - Project Management Professional certification is preferred.
Technical Skills & Abilities
- Able to handle multiple projects where the total project’s values exceed $5MM.
- Ability to converse about biologics and pharmaceutical manufacturing topics.
- Ability to work independently or in collaboration with others.
- In-depth understanding and application of project management principles, concepts, and practices,
- Proficient in current Good Manufacturing Practices and other applicable FDA, USDA and EU regulations.
- Excellent client-facing relationship building skills.
- Excellent written and verbal communication skills.
- Solid organizational skills including attention to detail and multitasking skills.
- Proficient in MS Excel, MS Word, MS Project, MS PowerPoint, MS Access and AutoCAD Lite.
- Must be willing to travel regionally and/or nationally throughout the U.S.
Travel
- Based in Denver CO but willing to travel regionally and/or nationally throughout the U.S.
Salary Range
- $90,000 to $115,000 per year.
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.
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