Validation Engineer II - Site Based, Redmond, WA

Evotec•Redmond, WA

4d•$79,800 - $109,250•Onsite

About The Position

The primary focus of this job is to support manufacturing and laboratory equipment, systems, facilities, and utilities commissioning, qualification and validation activities required in early phase manufacturing to late-stage programs into PPQ/ commercial biologics manufacturing. These responsibilities span all phases of the lifecycle from system implementation and qualification to cleaning and shipping validation. This role will also work cross functionally and collaborate with other teams on validation projects.

Requirements

Bachelor’s degree in engineering science or related program with minimum 2 years relevant experience.
Proven experience in executing commissioning and validation activities of FUSE.
Understanding of GMP concepts and Quality systems necessary to execute validation activities.
Understanding of industry standards and best practices for a science and risk-based approach to qualification of systems, equipment, utilities, and/or facilities.
Knowledge of process equipment, utilities, operations, and engineering principles.
Experience in quality risk management.
Must possess problem-solving and critical thinking skills.
Good interpersonal, team, and collaborative skills.
Motivated, self-starter with strong mechanical aptitude.
Ability to work both independently and collaboratively across multiple disciplines in a fast-paced and dynamic environment.
Proven knowledge of cGMP requirements and experience writing manufacturing technical documents.
Experience leading technical projects and managing timelines with external collaborators and vendors.
Candidate must possess a strong focus on quality and attention to detail as well as effective task/ time management organizational skills.

Nice To Haves

Understanding of biologics manufacturing process and process automation (e.g. DeltaV).
Experience with single-use technologies and systems.
Previous work experience with Complex Equipment, Distributed Control System (DCS), Building Automation Systems (BAS), PLC, SCADA, PI, and MES will be a plus.
Working knowledge of utilities and facilities, computerized systems, analytical equipment, process validation and clean validation methodologies.
Significant contributor to multi-disciplinary teams at the functional level.
Authority inspection or audit support involvement.

Responsibilities

Execute FUSE commissioning and validation activities for early stage clinical manufacturing, late-stage molecule/ commercial manufacturing and/or PPQ campaign support.
Generate and review technical documentation including validation lifecycle documents, validation protocols and associated reports related to the equipment validation lifecycle.
In collaboration with cross functional teams, develop Validation Master Plans, provide process knowledge to support the validation execution and risk assessments.
Lead the development and implementation of templates and validation workflows.
Support the generation of governance policies and related SOPs for commissioning of FUSE.
Support validation deviation resolution including troubleshooting and root cause analysis.
Support the periodic review of qualified/validated FUSE across JUST WA sites.
Support inspection readiness activities, Health Authority and Client audits, and support corrective actions based on audit findings.