Senior Process Engineer

2 weeks ago


Fishers, United States INCOG BioPharma Services Full time

Senior Process Engineer

INCOG Biopharma Services in Indianapolis, IN is hiring a Senior Process Engineer who will help lead and/or support with advancing our process improvement and operational excellence efforts to the next level. We are seeking a highly motivated individual with extensive experience leading capital projects installing and qualifying GMP pharmaceutical packaging equipment. Technologies include automated and manual visual inspection, labeling, assembly operations, cartoning, and serialization. After completion of the packaging expansion project, this role will transition into one responsible for short and long-term process improvements. The ideal candidate will have experience with biopharmaceutical based GXP manufacturing operations including technology transfers and process/equipment improvements.


The successful candidate will lead the technical team in packaging by providing technical assessments, rationales and approval for engineering and process changes as well as documentation pertaining to equipment lifecycle, qualification, audit responses, and validation to meet regulatory requirements. Shall have excellent oral/written communication skills and strong technical writing ability to lead and/or participate on teams with internal partners, customers, and vendors. Additionally, the candidate must thoroughly understand and be able to adapt to the changing needs of a contract manufacturing environment.


There is a growing need globally for more CDMOs (contract development and manufacturing organization) in the pharmaceutical industry to provide comprehensive services from drug development through drug manufacturing.


At INCOG, we are more than just a contract development and manufacturing organization. A better way to create more meaningful experiences. A better way to create a culture that everyone can thrive and succeed in. At our core, that is who we are—a dedicated team that believes we can always be better.

Join us at INCOG, a world-class CDMO for parenteral injectable drugs, shaping a new future for patients for yourself, our clients, and patients.


Job Functions:


  • Leading the packaging equipment specification, procurement, installation and qualification activities. This includes managing portions of the capital budget and providing routine project updates.
  • Monitor and analyze manufacturing data as necessary to provide support for process improvement and investigations.
  • Participate and support process FMEAs to understand process and product risks as a pre-requisite for process validation.
  • Ensure successful manufacturing process comparability and process validation runs by assessing risk, setting preventative measures in place, investigating, and troubleshooting equipment and process issues.
  • Lead and ensure systematic DMAIC based approach utilization for process/product related investigations to identify root cause and provide impact assessment to maintain routine manufacturing operations and determine process improvements for manufacturing.
  • Write technical documentation (protocols & reports for equipment/instrument qualifications, comparability, process, and manufacturing process validation testing) & work with vendors and suppliers to define requirements and understand functional specifications.


Candidate Requirements:


  • Knowledge of data management tools and RCM.
  • Bachelor’s degree or higher in chemical, electrical, or mechanical engineering, biochemistry, bioengineering, or related scientific field.
  • 5+ years’ experience in biopharmaceutical or other GXP regulated industry.
  • CMO/CDMO experience
  • Technical and/or lean six sigma certifications


Why INCOG?


  • Paid time off, based on tenure
  • 11 paid holidays
  • 401(k) plan with company match up, vested immediately
  • Choice of health & wellness plans
  • FSA and HSA options
  • Onsite wellness facility
  • Employee engagement activities; food trucks, monthly luncheons, fundraising events, team building competitions, offsite celebrations



  • Fishers, United States INCOG BioPharma Services Full time

    Job Functions:Leading the packaging equipment specification, procurement, installation and qualification activities. This includes managing portions of the capital budget and providing routine project updates. Monitor and analyze manufacturing data as necessary to provide support for process improvement and investigations. Participate and support process...

  • Senior MS&T Engineer

    4 weeks ago


    Fishers, United States INCOG BioPharma Services Full time

    Job Functions:MSAT Engineer is responsible for scaling up and transferring process into full scale manufacturing process based on data generated internally or received from the client. Select appropriate equipment and single-use components for GMP manufacturing and develop technical documentation such as Tech Transfer Plan, Gap Assessment, Process Flow...

  • Senior MS&T Engineer

    4 weeks ago


    Fishers, United States INCOG BioPharma Services Full time

    Job Functions:MSAT Engineer is responsible for scaling up and transferring process into full scale manufacturing process based on data generated internally or received from the client. Select appropriate equipment and single-use components for GMP manufacturing and develop technical documentation such as Tech Transfer Plan, Gap Assessment, Process Flow...

  • Senior .NET Engineer

    2 weeks ago


    Fishers Island, United States myGwork Full time

    This job is with Fiserv, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly. Calling all innovators - find your future at Fiserv. We're Fiserv, a global leader in Fintech and payments, and we move money and information in a way that moves the world. We...


  • Fishers, United States Flexware Innovation Full time

    DescriptionWHAT FLEXWARE DOES Flexware Innovation is the go-to engineering firm for forward-thinking manufacturers that need to integrate their business and production systems to maximize their resources. Founded in 1996, our highly-skilled teams of dedicated professionals work side-by-side with customers to leverage technology to solve real business...


  • Fishers, United States Levisonics Inc Full time

    Job DescriptionJob DescriptionAbout Us: We are a dynamic and innovative medical device startup developing a point-of-care portable blood coagulation testing device. Our full-time team currently comprises a CEO/Biomedical Engineer, and an Electrical Engineer. Job Summary: We are seeking a talented and experienced Senior Software Engineer to join our team...


  • Fishers, United States SME Full time

    The Opportunity: A Senior Geotechnical Engineer is responsible for business development, cross-selling SME services, and preparing projects and reports, as well as mentoring and leading team members to successfully complete assigned responsibilities. Responsibilities:Identifying and securing clients and business/project opportunities both independently and...

  • Engineering Intern

    3 days ago


    Fishers, Indiana, United States RQAW Corporation Full time

    Job DescriptionRQAW Corporation is seeking highly motivated and enthusiastic interns to join our team. As an intern, you will have the opportunity to gain real-world experience and develop valuable skills in a dynamic and fast-paced environment.Key Responsibilities:Work under the supervision of a project manager or senior-level team member to develop your...

  • Automation Engineer

    2 months ago


    Fishers, United States Flexware Innovation Full time

    DescriptionWHAT FLEXWARE DOES Flexware Innovation is a leading technology integrator that helps forward thinkers in manufacturing and related industries build comprehensive and long-lasting solutions with ease. Founded in 1996 and based in Indiana, our teams of talented engineers leverage technology to solve real business problems with teams of engineers...


  • Fishers, United States GAI Consultants Full time

    Description GAI Consultants is seeking an Engineering Manager in our Indiana Roadway Design Group to be responsible for leading the successful delivery of scope, schedule, budget, and quality for projects within the Midwest Infrastructure Business Sector of GAI's Transportation Business Unit. This position will directly manage and/or oversee all engineering...


  • Fishers, United States Noblesoft Technologies Full time

    Role: Software Test EngineerLocation: Fishers, INJob type: Contract to HireCandidate will need to be able to obtain a CLEARANCE from the Department of EducationYou will automate and test APIs, integrate and run scripts in our CI/CD pipelines, and set up operations for automated health checks. Solid SDLC knowledge and experience in an agile Scrum environment...


  • Fishers, United States Noblesoft Technologies Full time

    Role: Software Test EngineerLocation: Fishers, INJob type: Contract to HireCandidate will need to be able to obtain a CLEARANCE from the Department of EducationYou will automate and test APIs, integrate and run scripts in our CI/CD pipelines, and set up operations for automated health checks. Solid SDLC knowledge and experience in an agile Scrum environment...

  • Senior Project Manager

    3 months ago


    Fishers, United States RQAW Corporation Full time

    Job DescriptionJob DescriptionDescription:The Senior Project Manager (SPM) directly assists the Department Director in successful execution of the department’s objectives. They may have less experienced PMs and junior staff reporting directly to them. They will be responsible for managing larger or more complicated projects and will be called upon to help...


  • Fishers, United States Ascension Full time

    Details Department: Sterile ProcessingSchedule: 6a-2:30p, M-FHospital: Ascension St. Vincent Location: Fishers, INBenefits Paid time off (PTO) Various health insurance options & wellness plans Retirement benefits including employer match plans Long-term & short-term disability Employee assistance programs (EAP) Parental leave & adoption assistance Tuition...


  • Fishers, Indiana, United States RQAW Full time

    About RQAWRQAW is a dynamic and innovative company that values its employees and provides a supportive and collaborative work environment.Job SummaryWe are seeking highly motivated and enthusiastic interns to join our team in various departments, including Hydraulic Services, Roadway, Bridge, Survey, Water/Wastewater, MEP, Architecture, Admin, Construction...

  • Quality Engineer

    6 days ago


    Fishers, United States ROI Search Group Full time

    Job DescriptionJob DescriptionWe are seeking a Quality Engineer to join a Fishers, IN, manufacturing organization providing world-class systems, processes, and services for the Pharmaceutical and Healthcare industry. This position is full-time, 100% on-site in Fishers five days per week, and operates in a 24/7 environment. Therefore, the Quality Engineer...


  • Fishers, United States Flexware Innovation Full time

    WHAT FLEXWARE DOESFlexware Innovation is a leading technology integrator that helps forward thinkers in manufacturing and related industries build comprehensive and long-lasting solutions with ease.Founded in 1996 and based in Indiana, our teams of talented engineers leverage technology to solve real business problems with teams of engineers focused on...


  • Fishers, United States Ascension Full time

    Details Department: Sterile ProcessingSchedule: 6a-2:30p, M-FHospital: Ascension St. Vincent Location: Fishers, INBenefits Paid time off (PTO) Various health insurance options & wellness plans Retirement benefits including employer match plans Long-term & short-term disability Employee assistance programs (EAP) Parental leave & adoption assistance Tuition...

  • Automation Engineer

    6 days ago


    Fishers, United States GalaxE.Solutions Full time

    Play a central role in enhancing our automation capabilities for testing our core platform. Collaborate with business analysts, developers and stakeholders to write test cases for new changes and work within an Agile/ Scrum development process. Devel Automation Engineer, Automation, Software Developer, Development Engineer, Engineer, Business Analyst

  • MSAT Engineer

    7 days ago


    Fishers, United States INCOG BioPharma Services Full time

    Description The Manufacturing Science and Technology Engineer will be responsible for supporting all facets of Tech transfer, Process Validation, GMP Floor Support, and Continued Process Verification in accordance with current good manufacturing (cGMP) for clinical and commercial programs. This role will provide strong technical oversight to the business to...