Process Engineer III, NPI, Site Based
Evotec
full-time
Posted on:
Location Type: Hybrid
Location: Seattle • Washington • United States
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Salary
💰 $92,400 - $126,500 per year
About the role
- Lead stakeholders to implement the NPI process at J.POD Redmond and Seattle to support the start and rapid scale-up of commercial GMP manufacturing activities
- Partner with Product and Process Design to coordinate successful efficient scale-up and transfer operations and to ensure the successful integration of process knowledge into manufacturing operations
- Partner with supply chain to support Bill of Material development and demand planning for new products
- Partner with Engineering and Digital disciplines to conduct facility fit assessments and plans to support system updates needed for new product introduction
- Partner with Manufacturing to develop high-quality batch records, robust processes and innovative technology solutions for new product introduction
- Partner with Quality, Validation and Global MSAT to develop and implement process validation and comparability study activities leading to successful product registration
- Utilize the team’s technical skills and process knowledge to participate and/or lead investigations related to NPI activities
- Collaborate with impacted groups to develop and execute effective CAPA
- Apply Operational Excellence principles to lead continuous improvement in NPI activities
Requirements
- Masters (or Bachelors) degree in relevant field or related program with 3+ (5+) years of pharmaceutical/biotech experience
- Knowledge and experience with biologics drug substance tech transfer, including implementation of first-in-human and early stage clinical programs in manufacturing
- Knowledge and experience with late-stage clinical and commercial biologics drug substance manufacturing programs, including project leadership roles in process validation, PPQ commercial manufacturing
- Proven record of accomplishment and self-directed leadership in GMP pharmaceutical or biotechnology is required
- Knowledge and experience with cell culture, purification, and solution preparation operations using disposable-based manufacturing technologies
- Knowledge of US FDA CFRs and European EMA, including ICH guidelines, as they relate to drug substance biological manufacturing
- Good interpersonal, team, and collaborative skills are required
- Excellent verbal and written communication skills and ability to interface with all levels of the organization
Benefits
- 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
- generous paid time off and paid holiday
- wellness and transportation benefits
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
GMP manufacturingbiologics drug substance tech transferprocess validationPPQ commercial manufacturingcell culturepurificationsolution preparationdisposable-based manufacturing technologiesNPI processCAPA
Soft Skills
interpersonal skillsteam collaborationcommunication skillsleadershipself-directed leadershipcontinuous improvementstakeholder managementproblem-solvinginvestigation leadershiporganizational skills
Certifications
Masters degreeBachelors degree