Manufacturing Engineer - Bloomington, United States - Altec Group

Altec Group Bloomington, United States

2 weeks ago

Description

Aegis Worldwide

Manufacturing Engineer - 1st Shift

Bloomington, IN

$100k-120k Salary

If you are looking for a great company with an awesome company culture, consider this 1st shift Manufacturing Engineer role in the Bloomington, IN area Aegis Worldwide is partnered with a top tier manufacturer in Bloomington, IN We are looking for engineers that are experienced in managing and budgeting projects, troubleshooting/calibrating, and knowledgeable about FDA/GMP regulations APLLY NOW

Responsibilities:

Function as a process engineer / solution provider to operations teams.

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.

Assist in the search, selection, and management of service and equipment contractors to meet the needs of the business.

Assist in managing applicable contractors within the scope of the facility security and access and EHS program requirements.

Know, interpret and apply FDA regulations and industry norms relevant to company's engineering and maintenance/calibration programs.

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

Requirements:

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.

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.

Bachelors degree in an engineering or technical related discipline preferred. Associates degree and prior work experience will be considered.

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

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

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