What are the responsibilities and job description for the Senior Process Validation Engineer position at GBA Team?
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.
Scope of Responsibility: Lead process validation efforts for parenteral drug product manufacturing and finishing processes. Coordinate, execute, and oversee process performance qualification (PPQ) activities with cross functional project teams. Represent Validation in client interactions. Generate validation deliverables. Estimated Start ASAP. Duration 6 months
Essential Functions:
- Lead process validation projects of broad scope.
- Collaborate with clients, Validation and cross-functional team members to coordinate projects, resolve issues, and meet aggressive timelines.
- Represent Validation in client interactions and communicate client requirements to the broader Validation team as needed.
- Oversee execution of process validation (PPQ) protocols on the production floor on varying shifts as needed to ensure that protocol requirements are satisfied.
- Effectively manage multiple high priority validation projects effectively.
- Responsible for project deliverables such as VMPs, pFMEAs, PPQ protocols and reports, change control assessments, technical transfer assessments, as well as other client deliverables as required.
- Provide training for internal customers on protocol requirements and execution responsibilities.
- Provide technical support to Manufacturing troubleshooting and resolving process related issues.
- Participate in investigations and provide documentation for Deviations and CAPA based on OOS/OOT results or validation activities.
- Open to a flexible and fluid work environment with schedule flexibility to support multi-shift operations.
- Perform all job responsibilities in compliance with applicable regulations, standard operating procedures, and industry practices.
- Support Agency, customer, and vendor audits as a validation subject matter expert (SME).
- Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company's policies and practices.
- Perform all other tasks, projects, and duties as assigned.
Education and Experience:
- Minimum 7 years of CQV experience in a parenteral fill/finish environment.
- Ability to multi-task and manage multiple, competing priorities.
- Good oral and written communication skills
Travel: Possible travel required for FATs, Vendor Audits, etc. Travel costs would be 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.
