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    Manufacturing Engineer - Bloomington, United States - Singota Solutions

    Singota Solutions
    Singota Solutions Bloomington, United States

    1 week ago

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    Description

    Job Description# JD293Job Title:
    Manufacturing EngineerDepartment: EngineeringLocation: Bloomington, IN (Onsite)

    Position: 1st shift, 40/week, exemptGeneral Description including Skills and Physical Activity Requirements1. Function as a process engineer / solution provider to operations teams.2.

    Manage projects including the implementation of new facility, laboratory systems, and process equipment from design/specification, installation, and validation within project timelines and capital budgets with special emphasis on manufacturing support of sampling, dispensing, formulation, traditional and robotic filling, automated and sem-automated inspection, labeling and packaging equipment.3.

    Assist in the search, selection, and management of service and equipment contractors to meet the needs of the business.4. Assist in managing applicable contractors within the scope of the facility security and access and EHS program requirements.5. Know, interpret and apply FDA regulations and industry norms relevant to Singota's engineering and maintenance/calibration programs.6.

    Able to create standard engineering documentation (URS, functional specifications, FMEAs, validation protocols, standard operating procedures) as well as writing deviation investigations.7.

    Participate in client and regulatory agency audits as a subject matter expert.8.

    Work with all functional departments to ensure the requirements of the engineering and maintenance/calibration programs are being met as well as individual project timelines.9.

    Assist maintenance personnel in maintaining the operational compliance of manufacturing equipment, and support of facility, safety, and laboratory systems and equipment by performing preventive maintenance / calibration procedures, and assisting with validations in accordance with the facility work order and change control programs.

    This would include troubleshooting and working in the areas, beyond those in #2 above, of electronics, industrial controls, and mechanical and HVAC systems.10.

    Must be able to lift 50 lbs, operate a scissor lift, climb on ladders, work in tight spaces, and work with many types of tools and do so according to EHS requirements.11.

    Must be available to respond/react to critical alarms on off hours, weekends, and holidays in support of manufacturing operations.12. Able to work proficiently in Microsoft Office environment.13. Strong verbal and written skills are essential.14. Strong customer service mentality is required as a member of Singota Solutions.15. Comply with quality and safety management systems including requirements for documentation, training, system use, SOPs, processes and procedures.16.

    General support required of a company where everyone is expected to perform multiple tasks bothinside and outside their department to meet the needs of the business.

    RequirementsWork Experience and Education Requirements1.

    5 plus years experience in an FDA-regulated GMP engineering/maintenance environment working with facility systems and equipment and contractors with special emphasis on support of formulation and filling processes.2.

    3 years experience in working with clients and regulatory agencies to answer questions regarding internal programs and be able to respond to client questions and observations in an effective and timely manner.3.

    Bachelor's degree in an engineering or technical related discipline preferred. Associates degree and prior work experience will be considered.4.

    Previous experience in direct support of cGxP primary and secondary packaging operations with special emphasis on formulation and filling process and equipment.5.

    Able to work independently and be able to learn new things quickly - troubleshooter and problem solver aptitude necessary.6.

    Good communicator, both written and verbal, as these skills will be required in client and regulatory agency audits and creation of FDA required documentation.7.

    Detail oriented person with strong organization skills and customer service background (both internal and external).Benefits401(k)401(k) matchingDental insuranceHealth insuranceHealth savings accountLife insurancePaid time offTuition reimbursementVision insuranceSingota Solutions is an Equal Opportunity EmployerSingota is an equal employment/affirmative action employer.

    If you need accommodation for any part of the employment process because of a disability, please send an e-mail to or call to let us know the nature of your request.

    The voluntary self-identification forms used by Singota Solutions only to collect and maintain records required of employers doing business with the federal government.

    YOU DO NOT HAVE TO ANSWER THESE QUESTIONS TO BE CONSIDERED FOR EMPLOYMENT WITH Singota Solutions.

    If you do choose to answer these questions, any information supplied by you on this voluntary self-identification form will not affect your employment opportunities with Singota Solutions, which is an equal employment opportunity employer.

    If we need additional information or want to schedule an interview, we will contact you.

    If your qualifications do not match our current needs, we will keep your resume and/or application on file for one year.

    Thank you for visiting EMPLOYMENT OPPORTUNITIES at Singota Solutions
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