Process Engineer

Simtra BioPharma Solutions

$80K — $95K *
Pharmaceuticals & Biotech
Less than 5 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor's Degree in engineering
  • 3+ years experience as a process engineer in the pharmaceutical sector
  • Experience in aseptic manufacturing environments
  • Proficient in PLC, HMI, and Vision Systems
  • Understanding of enterprise software used in pharmaceutical operations
  • Hands-on experience with sterile filling machines and lyophilization equipment
  • Ability to read mechanical and electrical drawings, familiar with AutoCAD or similar design tools

Responsibilities

  • Lead project management for pharmaceutical engineering initiatives from inception to completion
  • Oversee specifications, budgeting, procurement, and scheduling of engineering projects
  • Manage installation, validation, and delivery of equipment upgrades and repairs
  • Provide regulatory support and troubleshooting for manufacturing equipment
  • Author investigations and CAPA documents, ensuring compliance and quality
  • Participate as a Subject Matter Expert (SME) during internal and external audits
  • Take ownership of change control and work order processes

Benefits

  • Comprehensive medical and dental coverage available from Day One
  • 401(k) plan with company match for retirement savings
  • Flexible spending accounts to manage healthcare expenses
  • Generous time-off program including paid holidays and parental leave
  • Education assistance program to support professional development
  • Employee ownership plan promoting shared success
  • Onsite amenities such as fitness facility, cafeteria, and credit union access
Full Job Description
Process Engineer: Simtra, Bloomington, Indiana.

Lead end-to-end project management for pharmaceutical engineering initiatives, overseeing specifications, budgeting, procurement, scheduling, installation, validation, and delivery of upgrades, repairs, and turnkey systems. Provide hands-on manufacturing and regulatory support through equipment troubleshooting, IQ/OQ validation, investigations and CAPA authorship, change control and work order ownership, and SME participation in regulatory, client, and internal audits.

Required qualifications:

The minimum requirement is a Bachelors Degree in engineering and three years pharmaceutical experience as process engineer.

Experience must include: working in aseptic manufacturing environment; Interfacing with PLC, HMI, Vision Systems and Building Management systems; Ability to use enterprise software commonly used in pharmaceutical manufacturing operations; Supporting filling machines involving sterile drug products, vile filling processes, lyophilization equipment, and associated manufacturing systems; Reading mechanical and electrical drawings and Knowledge of AutoCAD or equivalent component design knowledge.

Please send resumes to M. Delp, Simtra 927 S. Curry Pike, Bloomington, Indiana 47403.

In return, you'll be eligible for[1]:
  • Day One Benefits
    • Medical & Dental Coverage
    • Flexible Spending Accounts
    • Life and AD&D Insurance
    • Supplemental Life Insurance
      • Spouse Life Insurance
      • Child Life Insurance
    • 401(k) Retirement Savings Plan with Company Match
    • Time Off Program
      • Paid Holidays
      • Paid Time Off
      • Paid Parental Leave and more
    • Adoption Reimbursement Program
    • Education Assistance Program
    • Employee Assistance Program
    • Community and Volunteer Service Program
    • Employee Ownership Plan
  • Additional Benefits
    • Short and Long-Term Disability Insurance
    • Voluntary Insurance Benefits
      • Vision Coverage
      • Accident
      • Critical Illness
      • Hospital Indemnity Insurance
      • Identity Theft Protection
      • Legal and more
    • Onsite Campus Amenities
      • Workout Facility
      • Cafeteria
      • Credit Union

[1] Current benefit offerings are in effect through 12/31/26

Disclaimer

This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job. It may not be inclusive of all the duties and responsibilities of the job. Simtra reserves the right to make modifications based on business requirements.

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