Validation engineer
Validation Engineer (King Of Prussia, PA):
Responsible for supporting validation projects for clients, authoring and executing Validation Lifecycle documents such as Validation Master Plan (VMP), Validation Plan (VP), Compliance, Risk Profile (CRP), User Requirements Specifications (URS), Risk Assessments, Factory Acceptance Test (FAT), Site Acceptance Test (SAT), Commissioning, Installation Qualification, (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and Process Validation (PV) protocols/reports in accordance with corporate procedures.
Perform Validation Periodic Review for various systems including process equipment, computerized systems, and laboratory equipment.
Analyze information and provide solutions based on technical knowledge of the systems; identify and escalate gaps, develop gaps remediation plans, and implement corrective actions.
Draft, revise, and provide technical input with respect to Standard Operating Procedures, Work Instructions, and template development. Maintain validation life cycle documents in Quality Management System (QMS).
Perform equipment risk assessments to assess impact of system functionality, data integrity, and control product quality.
Participate in cross-functional teams to assist with deviations investigations, Corrective & Preventive Actions (CAPA), and change controls in Trackwise.
EDUCATION REQUIRED: Bachelor's Degree in Biosystems Engineering, Biotechnological Engineering, Mechanical Engineering, Civil Engineering or closely related field or foreign equivalent
TRAINING REQUIRED: N/A
EXPERIENCE REQUIRED: 2 years' experience as Validation Engineer
OTHER SPECIAL REQUIREMENTS:
Prior experience with Quality Management System Trackwise and Corrective & Preventive Actions (CAPA) Software
Occasional travel to unanticipated clients' sites locally required.
CONTACT: Submit Application for this role to Laporte Consultants Corp @ [email protected] w/Ref#VE25
Recommended Jobs
Math Success Manager (Philadelphia)
Are you a math education leader who wants to transform how math is taught in the classroom and see students become passionate about learning? Do you want to be part of a leading team that works close…
Service Manager
Job Description Job Description A Service Manager for an insurance agency plays a crucial role in ensuring the efficient operation of the agency's service and customer support functions. Their re…
Masters Level Therapist
First Episode Psychosis Recovery Oriented Counselor (Masters Level Therapist) The On My Way Program is a Coordinated Specialty Care approach to treating young people who have recently experienced t…
Track assistant professor - cultural anthropology
Haverford College seeks a tenure-track Assistant Professor in Socio-Cultural Anthropology. Haverford College invites applications for a tenure-track position in Socio-Cultural Anthropology at the r…
Operations Specialist
Bring your drive for excellence, teamwork, and customer commitment to Independence. Join us as we renew and reimagine the future of health care. Together we will achieve our missionto enhance the heal…
Medical Assistant - UPMCCentrlPAWeightMgtCtr
The UPMC Central Weight Management Center at Carlisle is looking for an experienced Medical Assistant to join their team. This individual should have great customer service skills and pre-authorizat…
PA or NP for Occupational Medicine for Central PA Hospital Employed Position
Nurse Practitioner or Physician Assistant to join Established practice with company enrollment in the hundreds. This position will be rewarding. M-F hours with NO CALL. New grads and experienced w…
Senior Software Engineer
Overview As part of the Technology Services team at Free Market Health, the Senior Software Engineer will be responsible for all aspects of application development. As part of a growing team in a …
Shift Captain (Internal)
MOD Restaurants make pizza to serve people, to contribute to a world that works for and includes everyone. We believe companies can and should be a force for good in the lives of the people they e…
Prep Cook
Working in our award-winning restaurants offers you a great job and competitive earnings, plus the following benefits: ~25% Employee Discount : 25% off the entire check for you and a guest at ANY …