Senior Validation Project Lead/Manager at GBA in Newark, New Jersey

Job Description:

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.


Scope of Responsibilities:


Compli is a full service engineering contracting and consulting services company with a life sciences division specializing in pharma, biotech, API, Medical Device and laboratory facilities. We are seeking an experienced Senior/Project Lead Validation Engineer to join our growing team. Compli differentiates itself through an integrated approach to engineering, construction commissioning and validation.


Essential Functions:

• 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 COMPI at client sites and interact confidently with clients, contractors, management and peers

• Bachelor•s degree in a related life sciences or requisite industry training and experience
• Minimum8 years concentrated CQV 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

• Will be working in Philadelphia PA area, but will be traveling to sites across the US.