GBA · 8 hours ago
Senior Validation Engineer
St Charles, MO
Full-time
Onsite
Senior Level
7+ years expGBA is an engineering firm specializing in Commissioning, Validation, and Regulatory Support Services for the Life Sciences industry. The Senior Validation Engineer will support client commissioning and validation projects, prepare and execute lifecycle documents, and manage multiple projects while ensuring compliance with regulatory standards.
Transportation
Responsibilities
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
Qualification
Required
Bachelor's degree in a related life sciences or requisite industry training and experience
7+ years GMP experience
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
Ability to work in on-site/field environments
Ability to sit, stand, climb, and work on active construction sites for extended periods
Ability to lift up to 25 pounds
Working outdoors in a broad range of climate conditions
Working around construction machinery
Company
GBA
GBA, along with its partner affiliates, provides an innovative approach to traditional architectural, engineering, construction, and advanced technology services, supporting a myriad of clients throughout the United States.
201-500 employees
Funding
Current Stage
Growth StageLeadership Team
George Butler
Founder
Company data provided by crunchbase