Sr. Engineer

Company Description QRC Group, LLC is a firm dedicated to offer services to the Pharmaceutical, Medical Devices and Chemical Industries in the validation and regulatory fields.

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Job Description

Senior Engineer is focuses on process support for Drug Substance operations, with a strong emphasis on process monitoring, data analysis, and continuous improvement. The ideal candidate will bring technical expertise, cross-functional collaboration skills, and a passion for driving operational excellence in a regulated environment.

Key Responsibilities

• Provide technical support for Drug Substance manufacturing processes, including troubleshooting and deviation investigations.

• Lead process monitoring activities: collect, analyze, and interpret process data to identify trends and opportunities for optimization.

• Collaborate with cross-functional teams (Manufacturing, Quality, Engineering) to ensure robust and compliant operations.

• Author and review technical documentation including electronic batch records, process validation protocols, and change controls.

• Utilize systems such as SAP, TrackWise, and document management platforms to support operations and compliance.

• Support technology transfers, scale-up activities, and implementation of process improvements.

Qualifications

Education & Experience:

• Doctorate (Ph.D.) in Engineering or related field

• Master's degree in Engineering + minimum 2 years of relevant experience

• Bachelor's degree in Engineering + minimum 4 years of relevant experience

Required Skills:

• Strong understanding of Drug Substance manufacturing processes and GMP regulations.

• Experience with process monitoring, data collection, and statistical analysis.

• Proficiency in SAP, TrackWise, electronic batch records, and document management systems.

• Excellent communication and problem-solving skills.

• Ability to work independently and in cross-functional teams.

Additional Information

All your information will be kept confidential according to EEO guidelines.