What are the responsibilities and job description for the Packaging Equipment Validation Engineer position at GBA?
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.
Summary:
This is a contract position: 4-8 weeks writing and executing IQ, OQ and PQ for packaging line equipment, in accordance with client procedures. Will be working on site in Saint Joseph, MO.
Essential Functions:
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.
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.
Summary:
This is a contract position: 4-8 weeks writing and executing IQ, OQ and PQ for packaging line equipment, in accordance with client procedures. Will be working on site in Saint Joseph, MO.
Essential Functions:
- Support client site with packaging line validation activities.
- Work in a GMP environment in lifecycle documentation development, protocol execution.
- 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
- Possess a minimum of five (5) years performing lifecycle packaging line validation in the biological manufacturing (GMP) industries.
- Bachelor’s degree: preferred. The equivalent combination of education/experience may be accepted in lieu of degree
- Experience with qualification of packaging lines required.
- Experience with ERP systems (SAP, QMS (Veeva Vault).
- Must be willing to travel to support on-site project work within the U.S.
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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