Computer System Validation 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:

• Support client site with equipment and computer-related systems validation activities.
• Work in a GMP environment in lifecycle documentation development, protocol execution and leading project efforts for equipment and related PLC’s, DCS, SCADA systems, MES, etc.
• Supporting identifying Gaps in Lifecycle documentation and leading efforts to correct the Gaps.
• Support the Equipment and Automation team to ensure they are achieving all identified goals and objectives
• All other duties as assigned.

Qualifications:

• Possess a minimum of five (5) years performing equipment and automation lifecycle computer-related systems validation in the aseptic fill/finish pharmaceutical manufacturing (GMP) industries.
• Computer Science bachelor’s degree: preferred. The equivalent combination of education/experience may be accepted in lieu of degree
• Experience with equipment automation systems (e.g., Honeywell, Allen-Bradley, Rockwell, Siemens, Delta-V, etc.)
• Experience with ERP systems (SAP, QMS (Veeva Vault), LIMS (MODO), PV Works)
• Proficiency in MS Office software (Excel, Outlook, PowerPoint)
• 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 staff as well as external vendors
• Ability to draft routine reports and correspondence with Senior Leadership

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.