Engineering - Validation Engineer
Company: HonorVet Technologies
Posted on: May 26, 2023
Job Description: This will be a hybrid role composed of both onsite and remote work. M-F. Candidate must be available to commute to Bothell Client Site.
The primary functions of this role will be to support Validation activities as they pertain to Jump in Bothell, WA. Qualification may include on-site equipment testing activities. The duties and responsibilities of the role are as follows:
--- Support equipment qualification projects
o Work cross-functionally with Validation, Quality, and System Owner groups to manage IQ/OQ/PQ execution in accordance with project timelines.
o Complete all validation package documents (e.g., IQ/OQ/PQ, Summary Report, Traceability Matrices) including management of stakeholder review and approval.
o Develop lifecycle documents for new assets. This includes Configuration Specifications (CS) and User Requirement Specifications (URS).
--- Support the Periodic Review and Requalification program as needed
o Complete Periodic Reviews and Requalification activities as needed
o Temperature mapping of temperature-controlled chambers using the Kaye Validator
--- Support other Validation projects/deliverables as needed
o This includes but is not limited to: Technical assessments for equipment maintenance events or changes, cleanroom classification studies, EMPQ, etc.
--- Bachelor's Degree in Engineering or Life Science
--- 2+ years of experience in a cGMP Pharmaceutical/Biologics/Cell Therapy Manufacturing facility, preferably in Validation or other Engineering capacity.
--- Experience writing and executing IQ/OQ/PQ protocols and Summary Reports
--- Experience with Cell Therapy equipment (e.g. Xuri Wave Bioreactors, temperature controlled chambers, etc)
--- Experience with ValGenesis, Blue Mountain/Maximo/SAP, Trackwise or other Quality Record Management system.
--- Temperature mapping experience, particularly with the Kaye Validator
5. Develops appropriate validation methodologies in collaboration with Operations management and Quality Assurance for Client projects.
6. Leads a portfolio of validation projects under strict deadlines to ensure stakeholder success and bulk drug supply.
7. Executes and/or leads multiple projects and technical work assignments as a point of contact for project stakeholders.
8. Provides validation subject matter expertise (SME), to multi-function teams, advises operations on validation matters, and defends their work before regulatory agencies.
9. Ensures alignment with Client directives and industry guidelines on validation.
10. Duties may include internal compliance or efficiency improvement efforts within department.
--- Specific technical skills with biopharmaceutical processing including a minimum of 6 years of experience developing and/or testing process automation system software (preferably Delta V batch). Understanding of S88 and batch processing operations required. Practical experience with large scale distributed control systems required.
--- Knowledge of engineering and science generally attained through studies resulting in a B.S., in engineering (chemical preferred), a related discipline, or its equivalent.
--- Relevant experience in a Validation role in the biopharmaceutical industry or its equivalent.
--- Mastery of SOPs, cGMPs and other compliance requirements and regulatory guidelines (FDA, EU) and the know how to work and manage within a regulatory environment.
--- Comprehensive DCS and PLC based experience, preferably gained in the pharmaceutical industry.
--- Knowledge of procedural batch processing automation in a Delta V environment.
--- Knowledge of a system life cycle validation techniques for automation software specification and development.
--- Familiar with construction techniques and automation system hardware installation practices.
--- Experience with dealing with recognized large automation providers (Emerson, Rockwell preferred).
--- Familiarity with distributed control systems and automation (GAMP) validation concepts allows this individual to participate in cross-functional validation efforts. A working understanding of lean principles is a suggested.
--- Demonstrated proficiency in project management, oral communication, and technical writing skills are required.
--- The successful candidate will possess the professionalism and technical competency required to represent the department before our stakeholders, regulatory agencies, and management.
Work both independently and in a team environment at all levels of the organization, in particular Quality, Engineering and Manufacturing Operations.
Work within all Site Facilities, which requires one to give a high attention to detail and on occasion to properly use Personal Protective Equipment (PPE).
Exercises sound judgment in making decisions and recommendations within generally defined practices and policies without management review. May make decisions and take action on standard cases without management review. May work on assignments that are extremely complex in nature where independent action and a high degree of initiative are required in resolving problems and developing recommendations. Acts as an advisor to subordinates and becomes actively involved as required to meet schedules or resolve problems. Erroneous decisions or failure to achieve results may have significant financial implications or cause significant delays in schedules.
Incumbent performs all tasks completely independently, determining methods and procedures on new assignments. Receives assignments in the form of objectives and establishes goals to meet objectives. Completes projects and unusual or complex assignments with only general review from manager. Identifies and reports any discrepancies from normal practices or procedures to management, recommending and implementing corrective actions, when consensus cannot be reached.
dditional Job Requirements:
Keywords: HonorVet Technologies, Seattle , Engineering - Validation Engineer, Engineering , Bothell, Washington
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