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Validation Engineer

Employer
ValSource Inc.
Location
Gaithersburg, MD
Closing date
Aug 20, 2022

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A$ A' "A' ?PositionsValidation CQV Engineer SummaryValSource is currently looking to identify several Commissioning, Qualification and Validation (CQV) Engineer's in the Capitol Region (Gaithersburg, Maryland area). These candidates will be full-time employees to support a variety of different commissioning, qualification, validation, and process engineering projects with our clients throughout the Capitol Region.Responsibilities Responsible for project generation and/or execution and project deliverables related to the CQV of various types of equipment in pharmaceutical biotech and ATMP facilities, laboratories and manufacturing environments as well as associated processes as applicable. Responsibilities include but are not limited to:Understand Risk Assessments, Impact assessments, and system boundaries.Interface with project manager (PM) and understand responsibilities for the CQV of utilities, laboratory, and process equipment.Must be able to work independently or in a team environment, interacting with individuals at all levels in an organization and departmental areas.Preparation and turnover of timesheets promptly for project manager/client review.Review of ETOP's.Understanding and generation of the documentation associated with the projects including, but not limited to Standard Operating Procedures (SOP's) Design Qualifications (DQ), Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), Installation Verification (IV), Operation Verification (OV), Installation Qualification (IQ), Operation Qualification (OQ), and Performance Qualification (OQ), Alarm Criticality Assessment (ASA), Data Integrity Assessment (DIA), System Impact Assessment (SIA), System Requirement Assessment (SRA).Experience with HVAC and Room Qualifications.Experience with CTU's and Thermal Mapping.Experience with Bio/Pharma process manufacturing equipment.Experience with Bio/Pharma packaging equipment.Experience with Bio/Pharma laboratory equipment (Micro & Analytical).Experience with Bio/Pharma utilities systems (laboratory, manufacturing facility).Understand the workings of engineering capital projects and working knowledge of owner's representative support as well as A/E firm support.Experience in Engineering and User Specifications and verification Education BS Degree in Engineering/ STEM discipline or related technical degree. Related experience in the Engineering and pharmaceutical fields will be considered. Requirements Strong organizational, excellent writing and communications skills. Must be able to work independently and in a team environment, interacting with individuals at all levels in an organization and departmental areas.Ability to be flexible to address both shifting priorities and changes in approach in dynamic work environments.Knowledge of Industry guidelines (ISPE, PDA), US and international regulations (FDA, ICH, ISO, EU) for validation of GMP facilities.Proficiency with Microsoft office including Word, Excel, and PowerPoint. Microsoft Project and Visio a plus.Experience in AutoCAD or Revit modeling is a plus.ExperienceThree to five years' experience with increasing responsibility in the validation/quality service of life sciences, biotech or other FDA regulated projects.Prior practical experience at a GMP facility in a Process Engineering, Facilities or Operations role with skills that transfer to CQV duties also considered.Ability to be flexible to address both shifting priorities and changes in approach in dynamic work environments.Understanding of EPCMV, Quality by Design and risk-and science-based approaches and tools for compliance are desired.Strong leadership, verbal communication, technical writing, project management tools and word processing skills.Experience related to the commissioning and qualification of clean/dirty utilities, HVAC, facility systems, process support systems, and process equipment.Experience with cleaning validation, process and utility systems validation, laboratory systems & equipment, thermal mapping, manufacturing equipment qualification & validation, etc.Generation and supporting the troubleshooting and close out of discrepancies and deviations.Experience in Computer system assessment and 21 CFR Part 11 experience is a plusOther InformationDue to the full-time nature of these opportunities with ValSource, employment agencies or independent contractors need not respond.In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire.About ValSourceValSource is one of the largest independent and employee-owned Validation Services Company in North America with over 300 full time Engineering, Commissioning, Qualification and Validation employees. ValSource returns validation to a scientific event which helps companies design, perform and better control manufacturing processes throughout all stages of the operations life cycle. Full-time employees are offered a competitive compensation package that also includes full benefits (medical, dental, vision, short- and long-term disability), 401k, paid time off (holidays and vacation), continuous training and development, Employee Stock Ownership Plan, discretionary bonus, etc.Equal Employment OpportunityValSource provides equal employment opportunities to all employees and applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, genetic information, military, and veteran

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