Job Specifications
Position: Entry-Level Validation Engineer(W2)
Location: NC (100% Onsite)
Duration: 12 Months
Top Skills (Foundational Requirements)
Life Sciences / Pharmaceutical industry exposure
Fundamental Validation & C&Q knowledge
Basic familiarity with DeltaV, MES, or automation systems
Key Responsibilities
Support C&Q lifecycle activities including URS, DQ, IQ, OQ, and PQ for automation and process systems.
Assist senior validation engineers with protocol execution, data collection, and deviation documentation.
Participate in cross-functional collaboration with Engineering, Quality Assurance, Manufacturing, and Automation teams.
Assist with the preparation, review, and organization of validation protocols, test scripts, and final reports in compliance with cGMP and regulatory standards.
Maintain validation documentation and traceability using electronic systems such as Kneat, GVault, or similar platforms.
Support change control activities, including documentation updates and impact assessments for validated systems.
Assist during internal audits and regulatory inspections by providing validation documentation and support materials.
Follow site SOPs, validation plans, and C&Q strategies to ensure compliance and consistency.
Required Qualifications
Bachelor’s degree in Engineering, Life Sciences, or a related discipline.
0–3 years of experience in validation, quality, automation, or pharmaceutical/biotech manufacturing (internship or co-op experience acceptable).
Basic understanding of cGMP, FDA, and regulatory expectations within a regulated environment.
Exposure to automation systems, process control, or MES platforms (academic or on-the-job).
Strong attention to detail and ability to follow procedures and documentation standards.
Good written and verbal communication skills.
Preferred Qualifications
Internship or co-op experience in pharmaceutical, biotech, or medical device manufacturing.
Introductory experience with DeltaV, MES, or automation validation.
Familiarity with validation documentation tools (Kneat, GVault, Veeva, or similar).
Willingness to work onsite in a manufacturing environment and learn hands-on validation execution.
About the Company
United Pharma Solutions is a professional company dedicated to business development in the pharmaceutical industry. Pharma Solutions uses its knowledge, experience and resources in the Pharma industry to to provide them with the best solutions for their client needs, suppliers and regulators. Our client references are the strongest testament to the exceptional results we deliver in partnership with them.
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