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Contract Msat Process Engineer Jobs in Indiana (NOW HIRING)

Contract Responsibilities: - Support process control systems, PLC/HMI platforms, instrumentation ... engineering, operations, vendors, and project teams on controls improvements - Support ...

Process Automation Engineer As a Process Automation Engineer, you will support the Clinton ... internal/contract resources, scheduling, and issue resolution * Identify and implement process ...

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Gary, IN 46406 (Onsite) Duration: 6+ Months Contract Job Overview Engineer II will support manufacturing process improvements in an FDA-regulated medical device environment, following design control ...

We are seeking an experienced Process Engineer to be the primary engineering liaison within our ... Maintain a thorough understanding of contract / drawing requirements for dispositioning quality ...

We are seeking an experienced Process Engineer to be the primary engineering liaison within our ... Maintain a thorough understanding of contract / drawing requirements for dispositioning quality ...

We are seeking an experienced Process Engineer to be the primary engineering liaison within our ... Maintain a thorough understanding of contract / drawing requirements for dispositioning quality ...

We are seeking an experienced Process Engineer to be the primary engineering liaison within our ... Maintain a thorough understanding of contract / drawing requirements for dispositioning quality ...

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Contract Msat Process Engineer information

What are the key skills and qualifications needed to thrive as a Contract MSAT Process Engineer, and why are they important?

To thrive as a Contract MSAT (Manufacturing Science and Technology) Process Engineer, you need a strong background in chemical or biochemical engineering, process optimization, and a relevant engineering degree. Familiarity with process simulation software (like Aspen or SuperPro), statistical analysis tools, and regulatory compliance standards such as cGMP is typically required. Excellent problem-solving, communication, and project management skills help drive cross-functional collaboration and process improvements. These competencies ensure efficient, compliant manufacturing processes and successful technology transfer in a highly regulated industry.

What are some common challenges faced by Contract MSAT Process Engineers during technology transfer projects?

Contract MSAT Process Engineers often encounter challenges such as aligning process specifications between sending and receiving sites, troubleshooting unexpected deviations during scale-up, and ensuring thorough documentation for regulatory compliance. Communication with cross-functional teams—including manufacturing, quality assurance, and R&D—is critical to anticipate and resolve issues quickly. Additionally, adapting to varying site capabilities and timelines requires strong project management and flexibility to deliver successful technology transfers.

What is a Contract MSAT Process Engineer?

A Contract MSAT (Manufacturing Science and Technology) Process Engineer is a professional who works on a temporary or project-based contract to support the development, optimization, and troubleshooting of manufacturing processes in industries such as pharmaceuticals or biotechnology. Their primary role is to ensure processes are efficient, compliant, and capable of producing high-quality products. They often collaborate with other departments, such as quality assurance and production, to implement process improvements, technology transfers, and scale-up activities. Contract positions typically mean the engineer is hired for a specific project or period rather than as a permanent employee.

What is the difference between Contract Msat Process Engineer vs Contract Chemical Process Engineer?

AspectContract Msat Process EngineerContract Chemical Process Engineer
CredentialsBachelor's in Chemical Engineering or related, certifications varyBachelor's in Chemical Engineering or related, certifications vary
Work EnvironmentManufacturing plants, chemical facilities, process optimizationRefineries, chemical plants, process design and improvement
Industry UsageOil & gas, petrochemicals, manufacturingChemical manufacturing, refining, pharmaceuticals

The Contract Msat Process Engineer and Contract Chemical Process Engineer roles share similar educational backgrounds and work environments, often within chemical and manufacturing industries. The main difference lies in their specific focus areas: Msat Process Engineers typically concentrate on process optimization and safety in manufacturing, while Chemical Process Engineers may focus more on process design and chemical reactions. Both roles require relevant engineering credentials and are vital in their respective sectors.

What are the most commonly searched types of Msat Process Engineer jobs in Indiana? The most popular types of Msat Process Engineer jobs in Indiana are:
What job categories do people searching Contract Msat Process Engineer jobs in Indiana look for? The top searched job categories for Contract Msat Process Engineer jobs in Indiana are:
What cities in Indiana are hiring for Contract Msat Process Engineer jobs? Cities in Indiana with the most Contract Msat Process Engineer job openings:
Infographic showing various Contract Msat Process Engineer job openings in Indiana as of May 2026, with employment types broken down into 1% As Needed, 80% Full Time, 17% Part Time, 1% Temporary, and 1% Nights. Highlights an 67% Physical, 9% Hybrid, and 24% Remote job distribution.

Manufacturing Science and Technology (MSAT)

Simtra BioPharma Solutions

Bloomington, IN • On-site

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Posted 27 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 Manufacturing Science and Technology (MSAT) role is part of a team of experienced pharmaceutical professionals responsible for the technical onboarding and process development of new drug product projects at Simtra. This includes designing the process(es) required for the new project. The Tech Transfer Senior Associate will work closely with a cross-functional group consisting of Program Management, Sales, Supply Chain, Process Validation, Research and Development (R&D), and others, during development and transfer of new projects to Simtra. This position is 100% onsite at the Bloomington facility and reports to the Sr. Technical Transfer Manager.
The responsibilities:
  • Lead the onboarding and process development activities for the manufacture of new drug products, including the supporting development studies
    • Lead the cross-functional team through technical activities, development studies and PPQ batches
    • Create technical transfer documents supporting this goal [Technical Transfer Plan, Process Development studies (i.e. mixing studies, filtration studies, purge studies, etc.), Demonstration batch records, PPQ master batch record]
    • Heavy participation/co-lead with Process Validation representative on PPQ strategy and protocol development
    • Lead during hand-off to the commercial team following PPQ batches
  • Provides technical support to daily manufacturing operations while being visible on the manufacturing floor and resolving issues during manufacturing
  • Leads process improvement activities
  • Independently conduct Non-Conformance Report (NCR) investigations and create, provide ownership, and implementation of Corrective Actions/Preventive Actions (CAPA)
  • Change Control Management (CCM) owner and impact assessment
  • Ownership of Fill Volume Dosing Qualification (FVOQ) documentation
  • Critical evaluation of product impact and responsible for advising if product meets release criteria and regulatory requirements
  • Participates in new project reviews to determine acceptable fit
  • Reviews Master Batch Records of junior colleagues and provides guidance
  • Independently represents Simtra in regulatory, client and internal audits as product/process Subject Matter Expert (SME). Ownership of audit responses and related CAPAs
  • Participates independently in client calls and on-site visits to discuss and set strategy for projects and issue resolutions
  • Standard Operating Procedures (SOP) owner & process subject matter expert (SME)
  • Perform filter troubleshooting
  • Develop and present in-depth SME courses on pharmaceutical industry topics
  • Mentors new hires in Technical Services Department and helps with training and on-boarding

Required qualifications:
  • BS degree, preferably in a science or engineering related field
  • 7+ years pharmaceutical manufacturing experience
  • 3+ years of applicable Technical Transfer/Process Development experience
  • In-depth knowledge of systems and equipment - including scales, mixing systems and mixing monitoring methods, aseptic formulations, fill volume limit setting, disposable formulation technology, homogeneity testing, control charting, identification and response to trends
  • Expertise in aseptic processing, sterile filtration, and Process Validation
  • Microsoft Office Suite advanced proficiency Word, Excel, and Outlook
  • Knowledge and ability to use enterprise software (JDE, BPLM, Minitab, Trackwise, etc.)

Physical / safety requirements:
  • Duties will require overtime work on occasion, including nights and weekends
  • Position requires sitting for long hours but may involve walking or standing for periods of time
  • Must be able to qualify for Grade A/B area gowning
  • Must be able to wear applicable 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
    • Short and Long-Term Disability 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
    • 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 12/31/24
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.
EEO is the Law
EEO is the law - Poster Supplement
Pay Transparency Policy
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To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy:
https://biopharmasolutions.baxter.com/simtra-recruitment-platform-privacy-policy