Senior Manager, Validation – Site MSAT

Just is seeking a highly motivated Senior Manager of Validation in MSAT team that desires a significant opportunity to improve worldwide access to biotherapeutics.   The primary focus of this job is to provide team and project leadership of validation activities for early phase manufacturing to late-stage programs into PPQ/ commercial biologics manufacturing.   The role is responsible for overseeing the validation process of Facilities, Utilities, Systems and Equipment (FUSE) to ensure compliance with industry standards and regulations. This includes supporting site-based validation requirements and  the implementation of network alignment strategy across JUST Evotec Manufacturing network. The team member will also work cross functionally and lead validation risk assessments and support site inspections. This role will include direct reports/management of validation engineers.

Responsibilities:

• Lead FUSE validation activities of early stage clinical manufacturing, late-stage molecule/ commercial manufacturing and/or PPQ campaign support.
• Development, review and approval of 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.
• Support the development and implementation of templates and validation workflows.
• Support the generation of governance policies and related SOPs for commissioning of FUSE.
• Lead the periodic review of qualified/validated FUSE across JUST WA sites.

Position Requirements:

• Bachelor’s degree in engineering science or related program with 8+ years relevant experience or 6+ years of relevant experience with an MS.
• Proven experience in leading commissioning and validation activities of FUSE.
• Understanding of GMP concepts and Quality systems necessary to execute validation activities.
• Experience developing and providing oversight to validation strategies throughout the FUSE validation life cycle.
• Understand computer system validation requirements.
• Understanding of FDA CFR 21 Part 11 compliance
• Strategic mindset, ability to organize, analyze/interpret, and effectively translate validation expertise into procedures/templates
• Good interpersonal, team, and collaborative skills
• Excellent oral and written communication skills
• Demonstrated skills managing or mentoring junior engineers or direct reports.  
• 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:

• Working knowledge of biologics manufacturing process equipment, engineering and utility systems, DeltaV automation systems, and Manufacturing Execution Systems
• Have experience leading validation projects from early stage to late stage manufacturing.
• Experience with single-use technologies and systems
• 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 $112,560 to $154,100;  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.