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Validation Specialist III - De Pere, United States - Moriah Engineering
4 weeks ago
Description
Job Description Job Description Salary:
OVERVIEWAs a Validation Specialist III you will be responsible for generating SDLC documentation and validating/qualifying the systems used to develop and/or manufacture products within our assigned client base.
You will ensure systems are running according to necessary specifications and operate within regulations to ensure data integrity and the production of quality products.
Additionally, you will serve as a subject matter expert (SME) for Validation projects.RESPONSIBILITESExecute multiple large, assigned projects according to our clients needs, within multiple sites.
Coordinate/oversee the development of new processes or troubleshoot existing ones.
Generates System Development Life Cycle documentation, including, but not limited to:
Impact Assessments, User/Functional Requirements, Design/Functional Specifications, Traceability Matrix, ERES Assessments, Development Testing documents, Factory Acceptance Tests, Site Acceptance Tests, Installation and Operational Qualification Protocols, Commissioning documents, and ReportsSchedules and executes validations/qualifications per Standard Operating Procedures (SOPs) and regulatory guidelines.
Coordinates and communicates all testing within company resources, affected functional groups and upper management teams and evaluates test results.Executes equipment, facility, utility, computer system, and Automated Process Control validation studies to include protocol preparation, scheduling, protocol execution, analyze data and compose a final report.
Participates and presents data in Regulatory Agency, Customer, Corporation and Internal audits.Thorough understanding of risk based validation for computerized systems, industry standards and best practices for computer system validation.
Participates and provides expertise in developments/ improvements to validation programs as needed to remain current with cGMPs and industry standards.
Participates and leads teams assembled to specify, install, validate, troubleshoot and maintain systems and equipment.Conducts Validation deviations and/or participates in deviation investigations to identify root causes and define corrective and/or preventative actions (CAPA)Apply validation knowledge for manufacturing/packaging/utilities equipment in the to pharmaceutical/medical device/ food and beverage industries.
Perform all necessary engineering analysis and submit recommendations, as required.Create project documentation and procedures (SOP) to meet with customer requirements.
Create acceptance criteria and conduct acceptance tests, if applicable.
Manage the deliverables to agreed schedule and scope of work.
Maintain excellent communications with internal/external upper management and colleagues of other functional areas to assure consistency with customer policies, procedures, and processes.
Participate and lead staff meetings, as requested, and provide periodical project status reports.Any other duty assigned by supervisor, related to project, company or client needs.
QUALIFICATIONSBS/BA degree in science, engineering, manufacturing technology or closely related field is required.
Minimum of 5 years of relevant experience in validation is preferred.
Excellent attention to detail and extensive knowledge of FDA Regulations/Guidance or Good Manufacturing Practices is required.
Technical knowledge and experience with validation / qualification processes, equipment, utilities, facilities and/or computer systems is required.
Must be proactive, have experience with high performance teams, strong interpersonal and project management skills.
Must be able to interact with varying levels within the company and customers, including upper management.
Ability to work both independently and in partnership with others; proven ability to use initiative and drive to achieve results.
Project management thorough concepts:
timeline follow up, schedule reviews, predecessor.
People skills for interdisciplinary share.
Proven experience withDelta V, Data Integrity, SDLC, IOQ, Electronic Validation, DMSSelf-driven and schedule oriented.
Ability to evaluate compliance issues.
Strong conflict resolution skills.
PREFERRED QUALIFICATIONSValidation experience as related to sterile products and medical devices is preferred.
Strong knowledge of electrical drawings, P&ID, and network diagrams preferred.
Validation certification preferred.
HMI and PLC knowledge, preferred.
PHYSICAL/MENTAL REQUIREMENTSMust be able to lift and carry light loads as necessary in conducting testing.
May involve standing for long periods of time.
May require extended working shifts.
Must be able to wear proper gowning and PPE in manufacturing areas as required. to meet GMP and/or OSHA requirements.
Must be able to climb ladders/steps.
Must be able to lift items of 25lbs.
Moriah Engineering Solutions is an Equal Opportunity Employer and considers applicants for all positions without regard to race, color, religion, ancestry, national origin, age, gender identity, gender expression, sex/gender, marital status, sexual orientation, physical or mental disability, medical condition, military/veteran status, basis of genetic information, or any other group protected by law .
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