Senior Validation Engineer

GBA Team•Saint Charles, MO

1d•Onsite

About The Position

Build Your Future with GBA/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. Compli is full services Commissioning, Qualification, Regulatory Compliance and On Demand services firm. 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 clients 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.

Requirements

Bachelors 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

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 clients 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.