Validation Engineer; Federal

Job Description

Must be a US Citizen for this federal contract. The Validation Engineer is responsible for performing validation and engineering activities, conducting development studies, analyzing and assisting in improving pharmaceutical systems and processes.

Design, review and execute validation document activities such as Factory acceptance test (FAT), Installation qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) for equipment/utilities/facilities and generate reports (interim/final) that summarize results, specifications and acceptance criteria.

Perform annual re-qualifications of equipment, facility and utilities in accordance to GxPs. Create validation project and progress reports - weekly and monthly.

Participate in evaluation of failures and out-of-specification results impacting compliance with quality, safety and other design requirements. Provide technical inputs and develop strategy for various equipment transfer projects and provide regular status updates to department and program management.

Work closely with maintenance, facility and metrology teams to complete new equipment installation, calibration and qualification activities in accordance to validation master schedule. Perform engineering assessment and write investigation reports for any non-conformance.

Assist with engineering projects and perform other duties as assigned.

Bachelor's Degree (BA/BS) in Chemical, Biochemical, Mechanical Engineering in Pharmaceutical manufacturing, Engineering, Science or a relevant field – required.

2 to 4 years of experience, with a minimum of 2 years of direct validation experience.

• Proficient in MS Office – Advanced
• Excellent technical writing skills – Intermediate
• Excellent oral and written communication skills – Advanced
• Must be able to follow direction and execute assigned work independently after initial training is completed – Advanced
• Ability to work both independently and in conjunction with a team – Advanced

Read, understand and verify piping & instrument diagram, engineering layout, drawing and documents. Prior experience with process qualification and media simulation is a plus.

Frederick, MD

Federal Contract (US Citizenship is a MUST)

All your information will be kept confidential according to EEO guidelines.