QA Computer System Validation Engineer B.Braun -
Irvine, CA
We are currently seeking a Validation Engineer/Specialist who will provide specialized knowledge in computer and control system validation for pharmaceutical and medical device manufacturing processes and related products; provide Facility, Equipment and Process Qualification technical expertise. Author validation documents and execute validations of equipment control systems and computer systems.
1. Interface effectively with management personnel in IT, Engineering, Quality, R&D, and other technical disciplines.
2. Provide technical decision making regarding validation strategies and requirements for projects.
3. Prepare computer system requirement documents, including user requirements, process flow charts, functional specifications, design specifications. Contribute to the creation of Standard Operating Procedures and training materials.
4. Author and approve computer system validation plans, validation protocols, test case scripts, risk assessments, traceability matrices, validation reports, and other documents supporting computer system validation for new and existing manufacturing equipment, processes and products.
5. Perform, coordinate and manage computer system testing.
6. Represent Company in contacts with regulatory agencies, including interface with FDA inspectors and presentations to FDA management personnel.
To qualify for this position, candidates must meet the following qualification guidelines:
REQUIRED:
BS degree in a technical or scientific discipline with multiple courses in computer systems.
Two+ years experience in computer system validation for equipment, facilities and manufacturing processes in a medical device or pharmaceutical company.
Two+ years in general programming to include Visual Basic, SQL, Java and other programming languages in current use.
Experience in requirements definition.
DESIRED:
Experience with SAP and LIMS.
KNOWLEDGE:
Industrial Quality Control, Quality Engineering, Quality Assurance and Validation.
CFRs and their application to Medical Devices and Pharmaceuticals.
Software packages supporting statistical data analysis, word processing, flow charting, and project management.
Familiarity and understanding of manufacturing methods related to the production of medical devices and pharmaceuticals.
Familiarity and understanding of technical disciplines related to Quality Control, including Engineering and Sterilization Assurance.
General knowledge of computer hardware and software, including an understanding of software development.
SKILLS/ABILITIES:
Use of computers and peripherals related to validation execution and document authoring.
Communication skills, both verbal and written, commensurate with interfaces at the management level.
Ability to work independently and as a team member.
Ability to work with Consultants/Contractors to achieve projects' validation objectives.
Ability to analyze, investigate and propose approaches to technical and regulatory issues.
Ability to design, execute and analyze manufacturing process validation studies.
Ability to manage multiple concurrent tasks/studies.
Ability to execute the Validation Plans for medical device and pharmaceutical product manufacturing equipment and facilities.
B.Braun offers an excellent benefits package, which includes healthcare, a 401(k) plan, company sponsored pension, and tuition reimbursement. To learn more about B. Braun and our safety healthcare products or view a listing of our employment opportunities, please visit us on the internet at www.bbraunusa.com. An affirmative action - equal opportunity employer.
Through its "Sharing Expertise®" initiative, B. Braun promotes best practices for continuous improvement of healthcare products and services.
Aesculap - 10 months ago
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