Pharma Process Engineer — Lead Upgrades & Compliance

Simtra US LLC; Bloomington (IN); Hybrid; USD 85,000 - 120,000; Full time

Benefits offered by this job

Medical & Dental Coverage

Flexible Spending Accounts

Life and AD&D Insurance

401(k) Retirement Savings Plan with 1:

Time Off Program

Paid Holidays

Paid Time Off

Paid Parental Leave

Adoption Reimbursement Program

Education Assistance Program

Employee Assistance Program

Community and Volunteer Service

Employee Ownership Plan

Short and Long-Term Disability

Vision Coverage

Identity Theft Protection

Legal and more

Onsite Campus Amenities

Workout Facility

Cafeteria

Credit Union

Job summary

Simtra BioPharma Solutions in Bloomington, IN, seeks a Process Engineer to lead end-to-end pharmaceutical engineering projects—overseeing specifications, budgeting, procurement, scheduling, installation, validation and delivery of upgrades and turnkey systems.

The role includes hands-on manufacturing support, IQ/OQ validation, investigations, CAPA authorship, change control and audits with clients and regulators.

Qualifications

• Bachelor degree in engineering and 3 years' pharmaceutical process engineering experience.
• Experience in aseptic manufacturing environment is required.
• Familiarity with PLC/HMI/vision systems and BMS is needed.

Responsibilities

• Lead end-to-end project management for pharmaceutical engineering initiatives.
• Oversee specifications, budgeting, procurement, scheduling, installation and validation.
• Provide hands-on manufacturing and regulatory support, including IQ/OQ validation and CAPA handling.

Skills

Aseptic manufacturing

PLC interfacing

HMI interfacing

Vision Systems

Building Management Systems

Reading drawings

Education

Bachelor's Degree in Engineering

Tools

AutoCAD

Job description

Simtra BioPharma Solutions in Bloomington, IN, seeks a Process Engineer to lead end-to-end pharmaceutical engineering projects—overseeing specifications, budgeting, procurement, scheduling, installation, validation and delivery of upgrades and turnkey systems.

The role includes hands-on manufacturing support, IQ/OQ validation, investigations, CAPA authorship, change control and audits with clients and regulators.