What are the responsibilities and job description for the Computer System Validation Consultant position at 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 todays world, its 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.
Computer System Validation Consultant - Compli
Responsibilities:
- Involved in the validation of lab systems, including computer systems and computerized equipment, in accordance with client procedures.
- Support client site with computer-related systems validation activities.
- Work in a GMP environment in lifecycle documentation development, protocol execution and leading project efforts for computerized systems including laboratory, computer, and LIMS systems, etc.
- Supporting identifying Gaps in Lifecycle documentation and leading efforts to correct the Gaps.
- Support the CSV 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 lifecycle computer-related systems validation in the biological manufacturing (GMP) industries.
- Computer Science bachelors degree: preferred. The equivalent combination of education/experience may be accepted in lieu of degree
- Experience with computerized systems (e.g., Laboratory, LIMS, 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:
- Working on site in St. Joseph, MO.
- Must be willing to travel to support on-site project work within the U.S. Travel and Living expensed are reimbursed.
Its more than just a job
At Compli, we are about innovative and intelligent people who want to solve problems. Were 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.
