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Process Engineer, Purification
Eli Lilly and Company. Provide technical assessment and support for drug substance API manufacturing of biologics, oligonucleotides, peptides, and bioconjugates .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in Chemical Engineering with a focus on drug substance API manufacturing processes, ensuring compliance with cGMP and quality standards. Proficient in process optimization, risk assessment, and technical documentation within a pharmaceutical or biotech environment.
Highest-signal resume keywords
Chemical EngineeringAPI ManufacturingProcess OptimizationDeltaVCGMP Compliance
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Process EngineeringRisk AssessmentChromatographyTFF SkidsHeat TransferMass TransferTechnical Report WritingRegulatory SubmissionsProcess Control SystemsLaboratory Design
Soft Skills
Analytical SkillsProblem-SolvingCommunication SkillsTeam CollaborationMentoring
Tools & Technologies
DeltaVOSI-PIDynochemAspenElectronic Lab Notebooks
Industry Keywords
BiologicsOligonucleotidesPeptidesBioconjugatesPharmaceuticalBiotechCMOCGMPQuality SystemHSE
About the role
Key responsibilities & impact- Provide technical assessment and support for drug substance API manufacturing of biologics, oligonucleotides, peptides, and bioconjugates
- Develop and sustain process knowledge
- Support processes and equipment, optimize processes, and manage equipment capabilities and assets
- Perform impact and risk assessments for chromatography skids/columns, TFF skids, and related unit operations
- Learn laboratory and plant designs for purification equipment, including automation recipes and procedures
- Ensure safety and compliance with company safety policies
- Ensure processing equipment complies with internal Quality System requirements, engineering standards, and cGMP requirements
- Assess rig fit using technical data packages, modeling, simulations, and/or experimental work to verify heat and mass transfer during plant scale-up
- Engage and communicate with HSE, Quality Assurance, Tech Services, Development, Operations, FUME/C&Q, Automation, Maintenance, Environmental Monitoring, and Manufacturing
- Author, review, or approve technical reports and regulatory submissions
- Maintain records and technical notebooks
- Identify and communicate quality issues proactively
- Develop or review project plans and timetables
Requirements
What you’ll need- BS or MS in chemical engineering or related discipline
- Minimum of 1-4 years of experience in a pharmaceutical, biotech, or CMO environment supporting process engineering of drug substance active pharmaceutical ingredient (API) manufacturing or development
- Authorized to work in the United States on a full-time basis
- No employer support or sponsorship for work authorization or visas
- Deep technical interest and understanding in Chemical Engineering
- Ability to work well in a team environment and serve as point of accountability
- Experience with DeltaV, OSI-PI, Dynochem, Aspen, and/or electronic lab notebooks
- Strong analytical and problem-solving skills
- Strong oral and written communication skills for diverse audiences
- Ability to work independently and as part of a diverse Process Team
- Understanding of process control systems
- Creativity to identify improvement opportunities and initiative to implement them
- Ability to guide and mentor others through processes
- Flexibility to meet business needs
Benefits
Comp & perks- Company bonus depending partly on company and individual performance
- Company-sponsored 401(k)
- Pension
- Vacation benefits
- Medical benefits
- Dental benefits
- Vision benefits
- Prescription drug benefits
- Flexible benefits, including healthcare and/or dependent day care flexible spending accounts
- Life insurance and death benefits
- Certain time off and leave of absence benefits
- Well-being benefits, including employee assistance program, fitness benefits, and employee clubs and activities