Validation Project Leader - Life Sciences

GBA Team•Lenexa, KS

20h

About The Position

Compli, LLC, a George Butler Associates affiliate, was founded in 2001 to provide commissioning, validation and regulatory support services to the life sciences industry. We serve pharmaceutical and life science companies across North America. With regard to regulations and compliance, its never been more important to understand the documentation and quality assurance activities as they relate to vendors, engineering, construction and contractors, which is why clients trust the Compli team.

Requirements

Bachelors degree in a related life sciences or engineering field
10 plus years of GMP experience
Ability to converse about scientific matters
Ability to manage a project team
In depth understanding and application of validation principles, concepts, practices and standards
Considered a Subject Matter Expert (SME) in multiple areas 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
Excellent written communication skills with emphasis in technical writing
Proficient in Microsoft Word, Excel, Power Point and Project
Must be willing to travel regionally and / or nationally throughout the U.S.

Nice To Haves

Preferred prior experience in performing CQV services on the following systems / equipment: Utilities including HVAC systems and Purified Water / Water for Injection Systems
Lyophilizers / Freeze Dryers
Spray Dryers
Aseptic Fill Lines and associated equipment
Blending Equipment
Demonstrated expertise in multiple aspects of system qualification and regulatory compliance (e.g., EMEA, GCP, GLP, GMP, QSR) and internal requirements employing regulatory guidance and industry standards

Responsibilities

Lead project teams related to the commissioning and qualification of equipment, facilities, utilities, process and cleaning validation
Support Client commissioning / validation for facility, utility, equipment, cleaning and process validation projects as needed
Develop project specific validation plans and strategy documents
Author and implement associated validation and quality system policies and procedures
Prepare and execute commissioning / validation documents as needed
Participate in any stage of clinical or commercial production including green field construction, facility renovation, new product development, product launch, or product/process upgrade
Drive and determine 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
Able to manage and execute multiple projects to meet clients priorities
Provide a practical approach to problem solving
Other duties as assigned