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 Validation Engineer to join our growing team. COMPI differentiates itself through an integrated approach to engineering, construction commissioning and validation.
Are you looking to be a part of a close-knit work community? Do you have experience in the Life Science industry? Will you represent Compli, LLC as an experienced CSV Engineer for our pharmaceutical manufacturing, biotech, and medical device client projects? Do you enjoy traveling the country and making a difference? If so, this could be the right opportunity for you!
The Engineer will work closely with the client to provide innovative solutions to our clients. We are experiencing growth as a firm and are seeking a qualified Engineer with expertise in CSV, and Automation. The ideal candidate will be a self-starter who takes pride in their work and actively pursues opportunities to learn and assist others when needed.
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
Requirements:
Bachelor•s degree in a related life sciences or engineering field
8 • 10+ years GMP experience
Ability to converse about scientific matters
Candidate must have sterile/aseptic facility CQV experience.
Thermal mapping experience is essential.
Sterilization/SIP experience a plus.
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
Experience with Sterile/Aseptic Filling.
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
Must be willing to travel regionally and / or nationally throughout the U.S
Candidate must be on site during the core hours M-F from 7am-3pm
