Fill/Finish Manufacturing Engineer (Packaging)
Regeneron
9 hours ago
On-site
East Greenbush, NY
Operations
Role responsibilities:
- Act as a technical SME for packaging areas within fill/finish manufacturing.
- Interface with Engineering, Validation, DP Process Development, Process Analytical Sciences, Combination Products, Regulatory, Quality Assurance, and Quality Control.
- Serve as manufacturing lead for tech transfer/tech transfer studies, investigations, innovative technology adoption, and continuous improvement.
- Design and execute process development and related studies on manufacturing equipment.
- Support equipment/new technology design, installation, and qualification.
- Manage change parts and recipe creation for new product introduction.
- Lead material/component selection, design, and approval; work with stakeholders and vendors to design, source, and implement materials.
- Perform functional evaluation of new components and raw materials for feasibility.
- Review SOPs, specifications, regulatory filings, and other controlled documents as needed.
- Support SOP development and revision for assigned equipment and processes.
- Drive innovation in fill/finish equipment and techniques.
- Recommend capital expenditures and support realization of capital projects.
- May represent manufacturing during regulatory and client audits.
- Track and trend technical/business process metrics.
- Up to 30% travel (domestic/international) during project phase.
Qualifications & skills:
- Knowledge of cGMP manufacturing environment; familiarity with packaging/labeling of liquid and lyophilized injectable products.
- Strong interpersonal, cross-cultural, communication, negotiation, and problem-solving skills.
- Confidence, high emotional IQ, ingenuity, creativity, and resourcefulness.
- Ability to work toward established goals individually or as part of a team.
- Ability to understand/listen to team and stakeholder needs.
- Technology transfer and equipment/process validation experience with parenteral fill/finish operations (preferred).
- Previous technical support experience (preferred).
- Experience operating/qualifying highly automated equipment (plus).
- Serialization/serialization systems experience (preferred).
Education/experience:
- BS in engineering.
- Engineer: 2+ years industry experience; Sr. Engineer: 5+ years industry experience (or equivalent education/experience).
Application instructions:
- Apply now.
- Act as a technical SME for packaging areas within fill/finish manufacturing.
- Interface with Engineering, Validation, DP Process Development, Process Analytical Sciences, Combination Products, Regulatory, Quality Assurance, and Quality Control.
- Serve as manufacturing lead for tech transfer/tech transfer studies, investigations, innovative technology adoption, and continuous improvement.
- Design and execute process development and related studies on manufacturing equipment.
- Support equipment/new technology design, installation, and qualification.
- Manage change parts and recipe creation for new product introduction.
- Lead material/component selection, design, and approval; work with stakeholders and vendors to design, source, and implement materials.
- Perform functional evaluation of new components and raw materials for feasibility.
- Review SOPs, specifications, regulatory filings, and other controlled documents as needed.
- Support SOP development and revision for assigned equipment and processes.
- Drive innovation in fill/finish equipment and techniques.
- Recommend capital expenditures and support realization of capital projects.
- May represent manufacturing during regulatory and client audits.
- Track and trend technical/business process metrics.
- Up to 30% travel (domestic/international) during project phase.
Qualifications & skills:
- Knowledge of cGMP manufacturing environment; familiarity with packaging/labeling of liquid and lyophilized injectable products.
- Strong interpersonal, cross-cultural, communication, negotiation, and problem-solving skills.
- Confidence, high emotional IQ, ingenuity, creativity, and resourcefulness.
- Ability to work toward established goals individually or as part of a team.
- Ability to understand/listen to team and stakeholder needs.
- Technology transfer and equipment/process validation experience with parenteral fill/finish operations (preferred).
- Previous technical support experience (preferred).
- Experience operating/qualifying highly automated equipment (plus).
- Serialization/serialization systems experience (preferred).
Education/experience:
- BS in engineering.
- Engineer: 2+ years industry experience; Sr. Engineer: 5+ years industry experience (or equivalent education/experience).
Application instructions:
- Apply now.