Principal Validation Engineer
Hayward, CA
Req ID 48709BR
Business Title
Principal Validation Engineer
Business
Global Quality
Sub-Business
BioScience Support
Country
US
State/Province
California
Location of Position
Hayward, CA
Shift_
1st
Job Description
This position is responsible for providing engineering support for the manufacturing of device and biologic products at the Baxter Hayward Facility.
The Principal Validation Engineer (V-PE) will contribute within a department of professional quality and validation engineers, and direct the team towards the vision established by senior management of achieving and maintaining a world-class quality manufacturing environment. The candidate will be a driven, hard-working, hands-on, high achiever that actively leads him/her self and others to the end of successfully accomplishing complex and multi-faceted tasks. The candidate shall demonstrate the proven capability to define, plan, and execute projects involving a diverse cross-functional team within the established boundaries of quality, time, and budget. Additionally he/she shall be a highly proficient communicator, both verbal and written, and be able to convey complex ideas and concepts to other team members that may have differing technical backgrounds. He/she shall be an excellent technical writer with a mastery over the English language. The candidate shall be a passionate advocate for Quality in all aspects, and be a constant driver for results. With these skills, the candidate shall be able to create and implement novel and innovative solutions in the Quality realm with logical persuasion and the utmost diplomacy and respect for his supervisors, peers, and subordinates. The candidate shall demonstrate effectiveness in task completion, decision-making, empowerment of others, people and project management, training, problem solving and team leadership. He/she shall lead Kaizan or equivalent focus type group activities as required, and may serve as a CAPA owner and lead investigator. The candidate must be recognized by all levels of the facility as an expert in their area and be able to demonstrate leadership ability. The candidate shall demonstrate a working understanding and knowledge of product/process development in the GMP Medical Device and Biotech arena. Additionally he/she shall be extremely proficient with test development, change implementation, Design Control, Design History Files, Device Master Records, Risk Assessment, and Verification/Validation. He/she shall also demonstrate excellent troubleshooting skills, always having keen insight and inclination towards Quality. The candidate shall most importantly display a customer service attitude when coordinating with various members of the team.
Displays standard engineering principles to resolve difficult problems, from conception to final design with team input.
Plans, schedules and leads project assignments in the evaluation, selection and adaptation of various engineering techniques, procedures, and criteria with minimal guidance.
With minimal guidance, schedules and leads a team through the planning and execution of a smaller project or defined piece of a larger project. This includes constructing detailed, accurate project schedules, interfacing with development groups and technical support groups.
Devises new approaches to complex problems through adaptations and modifications of standard technical principles.
Ability to prioritize multiple tasks.
Supervises/coordinates an engineer and/or technicians on assigned work.
Being the Subject Matter Expert (SME) for quality engineering issues, including organizing and executing projects related to product, process, and/or equipment design assurance and control.
Being Subject Matter Expert (SME) for validation issues, including organizing and executing projects related to product, process, and/or equipment validation.
Providing innovative and novel approaches for the execution of individual tasks within the various quality systems. This includes bringing to the table multiple new approaches, industry benchmarks, and best practices. He/she must be able to assess and communicate the impact of all approaches offered.
Creating and/or substantially rebuilding the various quality systems as needed. This includes proposing multiple new approaches based on external best practices. He/she must be able to communicate the impact of all approaches offered, advocate the desired approach to the facility team, and negotiate its successful implementation.
Assessing and determining the real and practical risks to product quality, regulatory compliance, GMP compliance, and business continuity. The candidate must be able to differentiate between risk and severity. Thereafter, if needed, he/she must be able to identify practical risk mitigation methods and allow the existence of risk conditions.
Providing clarity and direction to situations that are ambiguous or are not clearly defined in the existing procedures.
Providing guidance to customers and users regarding the use of the various quality systems.
Provide innovative solutions and drive Quality Systems initiatives for continuous improvement, regulatory compliance, exception management, and systems validation. When called upon, he/she may write, compile, execute or otherwise accomplish technical and administrative tasks as needed.
Conveying, in a highly proficient manner, concise and direct ideas to management, with defined recommendations for action.
Coordinating with Division and Facility team members to establish the best approach for implementation of Division Procedural initiatives.
Coordinating with Division and Facility team members, including Project Management Office, Regulatory, Marketing, Quality, Technical Operations, and Manufacturing groups to ensure new/changed processes and equipment are implemented within the regulatory requirements and approved project parameters.
Providing guidance to various internal customers for the Validation process related to components, in-process product, finished goods, packaging, and equipment utilizing industry best practices and regulatory expertise.
As required, approving, reviewing, and/or making recommendations for major changes. For each change he/she will establish or determine testing criteria, effectiveness tests, on-status release requirements, affected documentation, and state of validation.
Processing changes through the quality system, which includes data compilation, word processing, recording and entry of the changes via the paper and/or electronic change management systems, and other tasks that ensure that the changes are effectively accomplished with high quality and in a timely manner.
Supporting the overall Quality Management Systems
Accomplishing Certificates of Compliance that ensure that all local SOP's are in compliance with Baxter's divisional and corporate policies and procedures.
Accomplishing periodic reviews of documents which ensure that all controlled documents are reviewed for technical and formatting content on a regular basis.
Reporting metrics for the Quality Engineering and Validation systems as needed.
Utilizing experience regarding experimental design, fundamentals of probability, and statistical process control.
Performing risk management tasks (FMEA, Fault Tree Analysis, etc.)
Utilizing experience regarding test specification development, utilizing experimental design, and DOE in the medical device industry.
Performing verification and validation of manufacturing equipment and processes.
Writing and executing protocols.
P erforming verification and validation of analytical methods.
Job Requirements
Utilizing experience regarding implantable medical device products
Writing, revising, and reviewing SOPs.
Reviewing and/or revising documentation for technical and non-technical accuracy, completeness, and adherence to local and higher-level procedures.
Analyzing and summarizing technical data via common statistical tools and generating official reports.
Performing equipment commissioning and qualification.
Performing tasks regarding Product/Process Lifecycle documentation including writing and approval of URS, FS, SDS, etc.
Performing tasks regarding creating, managing, and querying databases and generating reports.
Performing risk-based assessments and determination of corresponding work requirements.
Writing and approving Deviations, Exceptions, CAPA's, and/or other Non-conformances.
Performing validation tasks regarding QC laboratory operations and test methodology, controlled environments and general manufacturing equipment and processes.
Performing validation tasks cell culture and purification processes.
Participating in audit situations.
Independently generating audit item remediation action plans and developing schedules and timelines accordingly.
Develop master quality plans and guides for medical device and pharmaceutical processes and the associated documentation as needed.
Demonstrate the ability to deliver innovative, cost-effective and timely solutions in a multiple project environment.
Proactively develop and maintain broad knowledge of the technical disciplines in own functional area(s); applies broad knowledge of trends.
Use deep subject matter/functional expertise, influence and process skills to help internal/external customers and stakeholders identify and meet their high priority needs while considering cultural and diversity implications.
Encourage informed Risk-taking and acts as a catalyst for innovation at Baxter BioScience;
Generate practical, sustainable and creative options to solve problems and create business opportunities, while maximizing existing resources.
Support materials qualification efforts as needed.
Reports directly to the Manger of Quality Engineering.
Supporting scheduled tasks during off-hour times when needed.
Possible travel (0-5%). • Display a solid understanding of theories/practices utilized by other disciplines outside primary area of expertise.
• Ability to convince management on courses of action with minimal assistance using both written and verbal methods.
• Effectively operate in and may facilitate cross-functional teams with guidance.
• Must be able to provide solutions that reflect understanding business objectives and cost implications.
• B.S. and 5 - 8 years related experience, OR M.S. and 2- 4 years related experience, OR Ph.D. and 1 - 2 years experience, OR ASQ certification as a Certified Quality Engineer (CQE). Chemical Engineering degree or experience preferred.
• A minimum of 5-8 years GMP medical device or finished pharmaceutical experience, of which at least 4 years directly as a Validation Engineer.
• Extensive experience with 21CFR 210, 211, 820 QSR's, current FDA guidance, and ISO13485 and their practical application.
• Extensive experience with Design Control, Design History Files, Device Master Records, and Risk Assessment.
• Extensive experience writing and executing verification and validation protocols. This includes V&V projects related to design, process, cleaning, sterilization, equipment, computer systems, utility systems, and facilities.
• Extensive experience writing and executing Quality Engineering and/or Validation tasks. This includes DOE, statistical analysis, test method and acceptance criteria determination, risk analysis and determination, process capability and variation studies, etc.
• Experience in leadership roles.
• Experience and responsibility over Design Control and/or Validation issues.
• Experience with project management.
Doing Work that Matters
Baxter provides its employees with comprehensive compensation and benefits. To view additional opportunities at Baxter and to learn more about the company, please visit our Web site at company website. EOE M/F/D/V.
