Senior Validation Engineer

Role: Senior Validation EngineerLocation: Baltimore, MD (Onsite)Duration: 12+ Months ContractRate: Open (Based on Experience)Job Description:We are seeking an experienced Validation Engineer with a strong background in biopharmaceutical or life sciences manufacturing environments. The ideal candidate will have hands-on experience with upstream process equipment and a solid understanding of validation practices.Key Responsibilities:* Perform commissioning, qualification, and validation (CQV) activities for manufacturing equipment.* Develop and execute validation protocols including IQ, OQ, and PQ.* Work with upstream equipment such as:* Bioreactors* Pump skids* Buffer vessels* Other related process equipment (“upstream equipment”)* Ensure compliance with GMP (Good Manufacturing Practices) and regulatory requirements.* Collaborate with cross-functional teams including Engineering, Quality, and Manufacturing.* Review and approve validation documentation and reports.* Support deviation investigations, CAPA, and change control processes.Required Qualifications:* Bachelor’s degree in Engineering, Life Sciences, or related field.* 3+ years (or more) of validation experience in pharma/biotech industry.* Hands-on experience with:* Bioreactors* Process skids* Buffer preparation systems* Strong knowledge of CQV lifecycle and documentation practices.* Familiarity with regulatory standards such as FDA, GMP, and ISO guidelines.Preferred Skills:* Experience in upstream processing environments.* Knowledge of automation systems (DeltaV, SCADA, etc.) is a plus.* Strong problem-solving and documentation skills.