Validation Engineer II, Site MSAT

Just is seeking a highly motivated Validation Engineer II in MSAT team that desires a significant opportunity to improve worldwide access to biotherapeutics.  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.

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

Position Requirements:

• Bachelor’s degree in engineering science or related program with 3-5 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 strong focus on quality and attention to detail
• Must possess problem-solving and critical thinking skills
• Good interpersonal, team, and collaborative skills
• Excellent oral and written communication 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

Additional Preferred Qualifications:

• 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.

This job description is intended to describe the general content of the job, and to identify the essential functions of and requirements for the performance of this job.  It is not to be construed as an exhaustive statement of duties, responsibilities, or requirements. Because job requirements evolve with the changing needs of Just-Evotec Biologics business, this description is subject to change and may be modified at any time, whether formally or informally.

The base pay range for this position at commencement of employment is expected to be $79,800 to $109,250;  Base salary offered may vary depending on the individual’s skills, experience and competitive market value. Additional total rewards include discretionary annual bonus, comprehensive benefits to include Medical, Dental and Vision, short-term and long-term disability, company paid basic life insurance, 401k company match, flexible work, generous paid time off and paid holiday, wellness and transportation benefits.

Evotec (US) Inc. is an Equal Opportunity Employer.  All qualified applicants will receive consideration for employment without regard to race, gender, age, disability, genetic information, gender expression, gender identity, national origin, religion, sexual orientation, or veteran status.