What are the responsibilities and job description for the Senior Validation Project Lead/Manager position at GBA?
Job: Senior Validation Project Lead/Manager
Location: Pacific Northwestern US
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.
What You'll Do:
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.
Location: Pacific Northwestern US
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.
What You'll Do:
- Support Client commissioning / validation for facility, utility, equipment, cleaning and process validation projects
- Prepare and execute commissioning / validation lifecycle documents
- Participate in any stage of clinical or commercial production including green field construction, facility renovation, new product development, product launch, or product/process upgrade
- Write summary reports for validation and qualification protocols
- Support project milestones, priorities and deadlines
- Write operating procedures for technical equipment and practices and procedures
- Perform system and process risk assessments and analyses
- Schedule and coordinate protocol execution with other departments including manufacturing, facilities and project management
- Develop project specific validation plans and strategy
- Able to manage and execute multiple projects to meet client’s priorities
- Provide a practical approach to problem solving
- Individuals must represent Compli at client sites and interact confidently with clients, contractors, management and peers
- Other duties as assigned.
- Bachelor’s degree in a related life sciences or requisite industry training and experience
- Minimum 8 years concentrated CQV experience in Pharma and Biotech manufacturing industries.
- First-hand experience with paperless validations systems (e.g., Valgenesis, Kneat, etc.)
- Ability to converse about scientific matters
- Ability to work independently or in collaboration with others
- In depth understanding and application of validation principles, concepts, practices and standards
- Considered a Subject Matter Expert (SME) in one area of validation
- Proficient in current Good Manufacturing Practices and other applicable regulations
- Experienced with all pertinent industry best practices (e.g., ISPE) including development and execution of all applicable system life cycle deliverables (e.g., URS, SRS, FRS, DDS, RTM, Unit, Integration, User Acceptance testing, FAT, SAT, Validation Planning, IQ, OQ, PQ, Final Validation Summary Report
- Demonstrated expertise in at least one aspect of system qualification and regulatory compliance (e.g., EMEA, GCP, GLP, GMP, QSR) and internal requirements employing regulatory guidance and industry standards
- Excellent written communication skills with emphasis in technical writing
- Proficient in Microsoft Word, Excel, Power Point and Project
- This role is not open to C2C staffing.
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.