ZipRecruiter

Log In

1

Senior Process Development Engineer Jobs in Bloomington, IN

General Motors

Senior Controls Engineer

Bedford, IN · On-site

$86K - $114K/yr

The Role As a Senior Process Controls Engineer, you will lead the development, execution, and continuous improvement of manufacturing controls across new and existing programs. This role supports ...

Optime Tech

Manufacturing Engineer

Columbus, IN · On-site

$68K - $87K/yr

Manufacturing Engineer Location: Columbus, IN (Onsite) Duration: 1+ Year (Potential for Extension ... This is a fully onsite position supporting manufacturing process development, production ...

next page

Showing results 1-20

All JobsProcess Development Engineer JobsSenior Process Development Engineer JobsSenior Process Development Engineer Jobs in Bloomington, IN

Senior Process Development Engineer information

See Bloomington, IN salary details

$65.4K

$105.7K

$148.7K

How much do senior process development engineer jobs pay per year?

As of Aug 7, 2026, the average yearly pay for senior process development engineer in Bloomington, IN is $105,664.00, according to ZipRecruiter salary data. Most workers in this role earn between $90,700.00 and $117,300.00 per year, depending on experience, location, and employer.

What does a senior process development engineer do?

A Senior Process Development Engineer is responsible for designing, developing, and optimizing manufacturing processes to improve efficiency, quality, and cost-effectiveness. They often lead teams in scaling up processes from the laboratory to full production, troubleshoot technical issues, and implement new technologies or methods. Additionally, they collaborate with cross-functional teams, including R&D, quality assurance, and production, to ensure processes meet regulatory and safety standards. Their expertise helps companies maintain competitive advantages and meet production goals.

What are the key skills and qualifications needed to thrive as a senior process development engineer?

To thrive as a Senior Process Development Engineer, you need a strong background in chemical or mechanical engineering, process optimization, and project management, typically supported by a relevant engineering degree. Familiarity with CAD software, process simulation tools (such as Aspen Plus or MATLAB), and Six Sigma or Lean Manufacturing certifications is often required. Excellent problem-solving, leadership, and communication skills help you coordinate cross-functional teams and drive continuous improvement. These skills are crucial for developing efficient, scalable processes that meet quality standards and business goals.

What are some common challenges a senior process development engineer may face when scaling up a new process from the lab to full production?

Senior Process Development Engineers often encounter challenges such as maintaining product quality and consistency when transitioning from small-scale laboratory experiments to large-scale manufacturing. This process typically involves troubleshooting equipment limitations, optimizing process parameters, and ensuring compliance with safety and regulatory standards. Effective collaboration with cross-functional teams, such as R&D, manufacturing, and quality assurance, is crucial to address these challenges and achieve a smooth scale-up. Adaptability and problem-solving skills are essential to navigate unexpected issues that may arise during this transition.

What is the difference between Senior Process Development Engineer vs Process Engineer?

AspectSenior Process Development EngineerProcess Engineer
CredentialsBachelor's or Master's in Chemical, Mechanical, or Industrial Engineering; experience in process developmentBachelor's degree in Engineering or related field; entry to mid-level experience
Work EnvironmentResearch and development labs, manufacturing facilities, cross-functional teamsManufacturing plants, production lines, process optimization teams
Industry UsagePharmaceuticals, chemicals, biotech, manufacturingManufacturing, chemical processing, consumer goods

The main difference is that Senior Process Development Engineers focus on developing and optimizing new processes, often in R&D settings, while Process Engineers typically oversee existing manufacturing processes to improve efficiency and quality. Senior roles involve more strategic planning and innovation, whereas Process Engineers focus on day-to-day process operations.

What are popular job titles related to Senior Process Development Engineer jobs in Bloomington, IN? For Senior Process Development Engineer jobs in Bloomington, IN, the most frequently searched job titles are:
What job categories do people searching Senior Process Development Engineer jobs in Bloomington, IN look for? The top searched job categories for Senior Process Development Engineer jobs in Bloomington, IN are:
Senior Process Development Engineer jobs near you

Sr. Process Validation Engineer

Simtra BioPharma Solutions

Bloomington, IN • On-site

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Re-posted 15 days ago

Job description

Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.
Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines - which are all directly injected into patients worldwide. As such, there is a strong emphasis on quality and continuous improvement at Simtra. We hold ourselves to the highest quality and regulatory standards.
While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging. Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.
Why join Team Simtra?Because we:
Make it HAPPEN - We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.
Make it TOGETHER - We work as one, respecting each voice and tapping into our unique strengths across teams-so we can solve problems in new ways.
Make it RIGHT - We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.
Make it COUNT - We take pride in our day-to-day work, knowing the impact we make - taking on challenges big and small to improve patient health.
This role:
The Senior Process Validation Engineer is a key member of the Technical Services organization, responsible for leading and supporting validation activities for sterile injectable manufacturing processes within a regulated pharmaceutical CDMO environment. This role focuses on process validation strategy, execution, lifecycle management, and maintaining the validated state to ensure compliant, robust, and inspection-ready operations.
The Senior Process Validation Engineer partners closely with Manufacturing, Quality, Validation, Engineering, Tech Transfer, Supply Chain, and Regulatory teams to implement risk-based approach that support safe, reliable, and scalable sterile drug product manufacturing. This position is full time and based onsite at the Simtra Bloomington facility.
The responsibilities:
  • Provide technical and strategic leadership for process validation of new and existing sterile injectable manufacturing processes, including formulation, compounding, filtration, aseptic filling, lyophilization, and terminal sterilization, as applicable
  • Own and drive lifecycle process validation strategy, ensuring risk-based, scientifically justified approaches aligned with FDA/EMA guidance, ICH expectations, and internal quality standards
  • Lead the development, review, and approval of key validation deliverables, including Process Validation Master Plans, risk assessments, protocols, control strategy elements, and final validation summary reports
  • Set validation direction and standards for parameters, sampling strategies, acceptance criteria, and statistical approaches; ensure consistent application across products, programs, and manufacturing areas
  • Serve as the primary validation interface with Manufacturing, Quality, Engineering, and external clients to ensure end-to-end process readiness for PPQ and commercial manufacturing
  • Lead process validation planning and execution for technology transfers, including assessment of development history, identification of validation gaps, definition of validation scope, and readiness for PPQ execution
  • Provide senior oversight and technical guidance for equipment, facility, and utility qualification activities, ensuring robust alignment with process validation requirements
  • Provide expert validation impact assessments for changes related to process, equipment, raw materials, analytical methods, and facilities, supporting change control and regulatory commitments
  • Establish and oversee continued process verification programs
  • Act as on-the-floor validation lead during PPQ execution, process confirmation runs, technology transfer campaigns, and high-risk or high-visibility manufacturing operations
  • Ensure validation documentation is inspection-ready, supporting internal audits, client audits, and global regulatory inspections
  • Serve as a SME during regulatory inspections and client audits; lead inspection preparation, participate in interviews, and support responses to inspection observations
  • Continuously improve validation practices, incorporating lessons learned, regulatory trends, and industry best practices to enhance efficiency, compliance, and product quality

Required qualifications:
  • Bachelor's degree in Engineering, Life Sciences, or a related technical discipline
  • 5-8+ years of experience in process validation, CQV, MS&T, or manufacturing support within a regulated pharmaceutical environment
  • Strong understanding of sterile injectable manufacturing processes and aseptic processing principles
  • Solid working knowledge of cGMP requirements and validation lifecycle concepts
  • Demonstrated experience authoring and executing process validation protocols and reports

Preferred qualifications:
  • Experience working in a CDMO environment and sterile injectable drug product manufacturing
  • Familiarity with equipment and facility qualification and CSV validation
  • Experience supporting regulatory inspections and client audits as a validation SME
  • Knowledge of continued process verification, process capability analysis, and lifecycle management
  • Experience working with electronic validation systems, MES, or electronic batch records

Physical / safety requirements:
  • Occasional overtime may be required, including evenings or weekends to support validation execution or manufacturing schedules
  • Position requires extended periods of sitting with routine walking and standing in manufacturing areas
  • Must be able to qualify for classified manufacturing area gowning as applicable
  • Must be able to wear required personal protective equipment (PPE)

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
  • 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.
Equal Employment Opportunity
Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
Data Privacy
To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy: https://simtra.com/privacy-policy/

Apply