Validation Engineer

Company : LanceSoft Inc

Country: United States

Location : Bothell, Washington

Post: Tue, 21 Mar 2023 06:46:19 GMT

Expires: Tue, 18 Apr 2023 23:59:59 GMT

Apply Job : Apply Online

—————————— Job Description ——————————

Job Title: Validation Engineer

Location: Bothell, Washington, 98021

Duration: 12 Months

This will be a hybrid role composed of both onsite and remote work. M-F. Candidate must be available to commute to Bothell Site.

Job Description:

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

Work cross-functionally with Validation, Quality, and System Owner groups to manage IQ/OQ/PQ execution in accordance with project timelines.

Complete all validation package documents (e.g., IQ/OQ/PQ, Summary Report, Traceability Matrices) including management of stakeholder review and approval.

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

Complete Periodic Reviews and Requalification activities as needed

Temperature mapping of temperature-controlled chambers using the Kaye Validator

Support other Validation projects/deliverables as needed

This includes but is not limited to: Technical assessments for equipment maintenance events or changes, cleanroom classification studies, EMPQ, etc.

Develops appropriate validation methodologies in collaboration with Operations management and Quality Assurance for Client projects.

Leads a portfolio of validation projects under strict deadlines to ensure stakeholder success and bulk drug supply.

Executes and/or leads multiple projects and technical work assignments as a point of contact for project stakeholders.

Provides validation subject matter expertise (SME), to multi-function teams, advises operations on validation matters, and defends their work before regulatory agencies.

Ensures alignment with company directives and industry guidelines on validation.

Duties may include internal compliance or efficiency improvement efforts within department.

Job Requirements:

Bachelors 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.

Preferred Experience:

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

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).