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Aditi Consulting

Senior Engineer

Aditi Consulting, New Albany, Ohio, United States, 43054

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3 days ago Be among the first 25 applicants This range is provided by Aditi Consulting. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more. Base pay range

$40.00/hr - $42.00/hr Payrate:

$40.00 - $42.00/hr.

Summary: In this role the Senior Engineer (Line Owner/System Owner) must work under general supervision, owns all the technical aspects in a manufacturing line. The processes were the SO/LO Engineer shall be familiar with are: characterization of process optimization strategies and/or solving problems of operational issues in the packaging operations, manufacturing, pilot technologies or capital projects. Applies basic engineering principles to the design and implementation of system modifications, experiments and/or capital projects. Organizes, analyzes and presents interpretation of results for operational issues or engineering projects of minor scope and complexity. At the same time, the System Owner/Line Owner Engineer shall be able to define design requirements to the service providers to fulfill area technical and equipment needs.

Responsibilities: Provide solutions to a variety of technical problems of moderate scope and complexity. Under general supervision we will evaluate, select and apply standard engineering techniques and procedures. Assistance given for unusual problems. Perform assignments that have clear and specific objectives and require investigation of limited number of variables. Initiate and complete routine technical tasks. Function as a technical specialist to equipment or systems regarding problem solving operations. Frequently become actively involved in daily operations when required to meet schedules or to resolve problems. Routinely audit the operational performance and regulatory compliance of a moderate number of equipment items or systems of complexity. Work with research, manufacturing, maintenance, process development, utilities, facilities, quality assurance and/or validation departments in developing requirements and recommendations for system modifications. Work under the direct supervision of project managers to complete design, engineering, and construction projects within schedule and budget constraints. Work with consultants, architects and engineering firms on development of standard design documents. Acquire and critique quotes for equipment modifications or installations. Generate rudimentary project cost estimates and schedules. Payrate:

$40.00 - $42.00/hr.

Summary: In this role the Senior Engineer (Line Owner/System Owner) must work under general supervision, owns all the technical aspects in a manufacturing line. The processes were the SO/LO Engineer shall be familiar with are: characterization of process optimization strategies and/or solving problems of operational issues in the packaging operations, manufacturing, pilot technologies or capital projects. Applies basic engineering principles to the design and implementation of system modifications, experiments and/or capital projects. Organizes, analyzes and presents interpretation of results for operational issues or engineering projects of minor scope and complexity. At the same time, the System Owner/Line Owner Engineer shall be able to define design requirements to the service providers to fulfill area technical and equipment needs.

Responsibilities:

Provide solutions to a variety of technical problems of moderate scope and complexity. Under general supervision we will evaluate, select and apply standard engineering techniques and procedures. Assistance given for unusual problems. Perform assignments that have clear and specific objectives and require investigation of limited number of variables. Initiate and complete routine technical tasks. Function as a technical specialist to equipment or systems regarding problem solving operations. Frequently become actively involved in daily operations when required to meet schedules or to resolve problems. Routinely audit the operational performance and regulatory compliance of a moderate number of equipment items or systems of complexity. Work with research, manufacturing, maintenance, process development, utilities, facilities, quality assurance and/or validation departments in developing requirements and recommendations for system modifications. Work under the direct supervision of project managers to complete design, engineering, and construction projects within schedule and budget constraints. Work with consultants, architects and engineering firms on development of standard design documents. Acquire and critique quotes for equipment modifications or installations. Generate rudimentary project cost estimates and schedules.

Qualifications:

Advanced degree in Mechatronics, Computer, Electrical, Mechanical, or Chemical Engineering Ideal Candidate: 4+ YOE, experience supporting a manufacturing line, and GMP or regulated environment experience. Knowledge and/or experience of pharmaceutical/biotech processes, especially in the area of final drug product operations Knowledge of pharmaceutical/biotech processes Familiarity with validation processes for Packaging areas Familiarity with serialization process and networking Familiarity with documentation in a highly regulated environment Ability to operate specialized equipment, tools and computers as appropriate. Ability to interpret and apply GAMPs and GMPs and familiarity with documentation in a highly regulated environment. Ability to apply engineering science to production. Able to develop solutions to routine technical problems of limited scope Comprehensive understanding of protocol requirements. Organizational, project management, problem-solving, as well as validation protocol, and technical writing capability Excellent communication (verbal/written) and presentation skills Demonstrated interpersonal skills including; collaboration, influencing, and facilitation Protocol and script testing Writing Dealing with and handling change Packaging Equipment Technical knowledge Analytical Problem Solving Comprehensive understanding of validation protocol implementation requirements as well as knowledge of validation processes and requirements as applied to new equipment installations Understanding of Operational Excellence and Lean Transformation in the Automation and Engineering Contex

Desired Skills:

Relevant pharma experience, experience starting up a new manufacturing line. Experience in a manufacturing environment, preferably GMP regulated or other highly regulated environment Experience working hands-on to solve technical problems on manufacturing equipment Great communication skills

Pay Transparency:

The typical base pay for this role across the U.S. is:

$40.00 - $42.00/hr

. Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education and experience and the benefits package you select. Full-time employees are eligible to select from different benefits packages. Packages may include medical, dental, and vision benefits, 10 paid days off, 401(k) plan participation, commuter benefits and life and disability insurance.

For information about our collection, use, and disclosure of applicant's personal information as well as applicants' rights over their personal information, please see our Privacy Policy (https://www.aditiconsulting.com/privacy-policy).

Aditi Consulting LLC uses AI technology to engage candidates during the sourcing process. AI technology is used to gather data only and does not replace human-based decision making in employment decisions. By applying for this position, you agree to Aditi’s use of AI technology, including calls from an AI Voice Recruiter.

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Seniority level

Seniority level Entry level Employment type

Employment type Contract Job function

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