What are the responsibilities and job description for the CQV Engineer position at Digicloud LLC?
Company Description
Digi Cloud LLC is a rapidly growing business consulting and staffing company dedicated to building effective partnerships with clients. We aim to provide tailored solutions by deploying highly skilled professionals to meet clients' business needs and drive their success from good to exceptional levels. Our vision is to lead in delivering outstanding value and exceeding customer expectations by taking an extra-mile approach. Guided by a results-driven philosophy, we focus on aligning client business ideologies with innovative and technology-driven processes.
Job Title: Validation Engineer – Fill/Finish Equipment
Duration: 12 Months
Job type: W2 Contract
Job Summary:
We are seeking an experienced Validation Engineer to support qualification and validation activities for pharmaceutical fill/finish operations. The ideal candidate will have strong experience with automated assembly equipment, particularly for pre-filled syringes and autoinjector systems.
Key Responsibilities:
Author and execute validation protocols using ValGenesis
Support validation documentation and workflows within Veeva
Perform IQ/OQ/PQ for fill/finish and assembly equipment
Lead qualification efforts for HERRO syringe assembly systems (Bausch Ströbel equipment)
Ensure compliance with 21 CFR Part 11 and data integrity requirements
Collaborate with manufacturing, QA, and engineering teams
Required Qualifications:
3 years of validation experience in pharmaceutical or biotech environments
Hands-on experience with fill/finish equipment (REQUIRED)
Experience with pre-filled syringe or autoinjector assembly systems
Strong knowledge of data integrity principles
Preferred Qualifications:
Experience with packaging equipment (cartoners, case packers, palletizers, serialization systems)
Familiarity with combination product manufacturing
Interested candidates can send me your resumes at naveen@digicloudllc.com