We're looking for a passionate and curious Process Engineer III to join our team. In this role, you'll have the opportunity to drive impactful projects, collaborate with bright minds, and explore uncharted territories.
Requirements
- Promotes a culture of safety
- Represents site MSAT on internal and external project teams as technical subject matter expert (SME) and interfaces with global MSAT, Manufacturing Operations and Quality functions.
- Possesses a deep understanding of downstream processes for the purification of biologics.
- Authors, reviews and approves process related documentation (technical documents, test protocols, batch records, process descriptions, SOPs)
- Leads complicated and multi-disciplinary change controls and will function as a lead for the project team.
- Partner with Quality, Validation and Global MSAT to develop and implement process validation and comparability studies leading to successful product registration.
- Is confident to act as a subject matter expert for regulatory and client inspection audits.
- Utilize technical skills and process knowledge to participate and/or lead investigations related to process issues/deviation. Collaborate with impacted groups to drive implementation of CAPAs from approval to closure & effectiveness check.
- Facilitates new product introduction by leading make-a-batch sessions and supporting technical training for manufacturing.
- Skilled at organizing data to optimize analysis and trending
- Experienced investigator and knowledgeable of root cause analysis tools (RCA)
- Support and on-call rotating to support 24/7 operations
- Apply Operational Excellence principles to lead continuous improvement ideas for downstream manufacturing.
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
- Flexible work
- Generous paid time off
- Paid holiday
- Wellness and transportation benefits
