Bioprocess Process Engineer - Drug Substance

BioSpace

Bloomington (IN)

On-site

USD 90,000 - 120,000

Full time

13 days ago

Application generator

A complete application in a minute — tailored resume and cover letter, ready to send.

Get past ATS filters

Benefits offered by this job

Leading pay and annual performance bon

Paid time off including 14 paid holida

Health Insurance

8% 401K contribution with companymatch

Parental & family leave benefits

Tuition Assistance

Life & Disability Insurance

Employee Referral Awards

Job summary

Novo Nordisk in Bloomington, Indiana is seeking an Engineer, Process - Drug Substance to support ongoing bioprocessing projects, troubleshoot equipment issues, and help manage budgets and schedules with cross-functional teams.

You will draft SOPs, participate in validation and commissioning, and guide equipment selections to meet GMP requirements, while contributing to a safer, compliant, and efficient manufacturing environment.

Qualifications

Bachelor's Degree in related field of study from an accredited university required and a minimum of two (2) years of relevant experience required
In lieu of Bachelor's Degree with two (2) years of experience, may consider a Master's Degree in related field of study from an accredited university with a minimum of zero (0) year of relevant experience required
In lieu of Bachelor's Degree with two (2) years of experience, may consider a PhD/PharmD in related field of study from an accredited university with a minimum of zero (0) year of relevant experience required
2+ years of Project Engineering related experience
We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

Responsibilities

Support selection and installation of bioprocessing equipment
Proactively and effectively partner with the commissioning/validation team, including operational protocol development, to implement compliance with FDA GMP requirements
Draft SOPs for bioprocess equipment operation, maintenance, and calibration
Identify improvements and efficiencies of preventative maintenance
Provide engineering guidance and execution on equipment projects
Perform hands‑on activities as needed to help troubleshoot equipment problems
Evaluate future capital bioprocess equipment projects
Maintain compliance in accordance with quality management system
Guide the specification and selection of bioprocessing equipment to support process needs
Draft, review, execute, and approve protocols and reports related to bioprocess equipment Validation
Act as primary Subject Matter Expert (SME) for bioprocessing equipment
Review and approve changes to bioprocessing equipment through the change control program to assess impact on validated systems
Assist in responding to customer/regulatory audit observations and corrective actions as it pertains to bioprocessing equipment
Identify and implement improvement opportunities for established production systems
Collaborate significantly with cross functional groups including Validation, Quality Control, Manufacturing, Process Development, and Facilities
Provide technical assistance and training for personnel
File and maintain controlled documents
Complete knowledge of varied aspects or a single specialized aspect of a discipline and some knowledge of principles and concepts in other disciplines
Apply technical and functional knowledge to conduct experiments/research in assigned area
May act as a technical resource within own work group/project team
Work independently to solve problems of moderate scope
Actively participate and suggest solutions to problems
Follow all safety and environmental requirements in the performance of duties
Other duties as assigned