Job description

Just is seeking a highly motivated Commissioning, Qualification and Validation Engineer that desires a significant opportunity to build and lead a cleaning validation program across multiple drug substance biologics manufacturing facilities. Additionally, the engineer will also support various commissioning, qualification, and validation (CQV) activities for manufacturing equipment, systems, facilities, and utilities.

Requirements:

• Bachelor’s degree in engineering science or related program with 5+ years of relevant biotechnology industry experience
• Understanding of industry standards and best practices for a science and risk-based approach to qualification of systems, equipment, utilities, and facilities
• Working knowledge of US FDA CFRs and European EMA, including ICH regulations
• Experience with quality risk management
• Experience with sampling techniques and cleaning cycle development
• Ability to perform New Product Introduction (NPI) assessments in support of cleaning validation for commercial readiness
• Knowledge of process equipment, utilities, operations, and engineering principles
• Strong understanding of process automation (*e.g. DeltaV)*
• Previous work experience with Distributed Control System (DCS), Building Automation Systems (BAS), PLC, SCADA, PI, and MES will be a plus
• Working knowledge of Quality Control equipment and systems

Responsibilities:

• Develop a phase appropriate approach to cleaning validation within the Just-Evotec Biologics Manufacturing facilities to meet regulatory and client requirements while ensuring a risk-based approach is followed.
• Implement cleaning requirements for New Product Introduction (NPI) efforts.
• Supporting the generation of key deliverables (in a phase appropriate compliance manner) including system impact assessments, criticality assessments, risk assessments, user requirements specifications, function specifications, and design specifications
• Lead in the generation, execution, review, and approval of commissioning and qualification protocols for manufacturing equipment, systems, facilities, and utilities
• Lead in the generation and execution of requirements traceability matrices and qualification summary reports
• Validation deviation resolution including troubleshooting and root cause analysis
• Periodic review and requalification of qualified equipment, systems, and utilities to ensure system remains suitable for its intended use and to verify compliance with appropriate industry regulations and company policies
• Supporting the development of the qualification and validation programs at Just
• Develop compliant and novel ways to comply with regulatory requirements
• Develop sitewide cleaning validation program
• Support inspection readiness activities, Health Authority and Client audits, and support corrective actions based on audit findings
• Supporting CQV activities at the Seattle site (early stage clinical)
• Supporting CQV activities across global expansion sites

Job Type: Full-time

Pay: $130,000.00 - $155,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Parental leave
• Referral program
• Retirement plan
• Vision insurance

Schedule:

• 8 hour shift
• Monday to Friday
• No nights
• No weekends

Supplemental pay types:

• Bonus pay
• Signing bonus

Application Question(s):

• Please outline your salary expectations.
• Please state your availability to start.

Work Location: One location

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