Job Description
Note: Must be a US Citizen for this federal contract.
The Validation Engineer is responsible for performing validation and engineering activities, conducting development studies, analysing and assisting in improving pharmaceutical systems and processes.
Essential Functions
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) which summarize results, specification and its acceptance criteria.
Performs annual re-qualifications of equipment, facility and utilities in accordance to GxPs.
Responsible for creating 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. Provide regular status updates to the department and program management.
Closely works with the maintenance, facility and metrology teams to complete new equipment installation, calibration, and qualification activities in accordance to validation master schedule.
Performs engineering assessment and writes investigation reports for any non-conformance.
Additional Responsibilities
Assists with engineering projects and performs other duties as assigned.
Education:
Bachelors Degree (BA/BS) BS: Chemical, Biochemical, Mechanical engineering in Pharmaceutical manufacturing, Engineering, Science or relevant field – Required
Experience:
Years of experience is between 2 to 4 years, A minimum 2 years of direct validation experience is required.
Skills:
Proficient in MS Office. - Advanced
Excellent technical writing skills - Intermediate
Excellent oral and written communication skills. - Advanced
Must be able for 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
Specialized Knowledge:
Read, understand and verify piping & instrument diagram, engineering layout, drawing and documents
Prior experience with process qualification and media simulation is a plus.
Work Locations: Frederick MD
Job: Engineering
Job Type: Federal Contract (US Citizenship is a MUST)
All your information will be kept confidential according to EEO guidelines.
Job details are sourced from the employer's original posting.
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