Senior Validation Project Lead/Manager

About the role

Compli, LLC is 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.

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
• 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

• Minimum 7 years CQV experience with aseptic liquid fill facilities, utilities, equipment and systems
• Bachelor's degree in a related life sciences or requisite industry training and 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

Qualifications

Must be able to travel to the East Coast or Midwest for extended on-site services.

Skills

Technical excellence, problem-solving, communication, and collaboration skills.

Benefits

Compli is 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.

Pay

N/A

Schedule

N/A