Sr. Engineer at QRC Group, Inc

Juncos, Puerto Rico, United States -

Full Time

Start Date

Immediate

Expiry Date

05 Feb, 26

Salary

0.0

Posted On

07 Nov, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Process Monitoring, Data Analysis, Continuous Improvement, Technical Support, Troubleshooting, Deviation Investigations, Cross-Functional Collaboration, Technical Documentation, Process Validation, Change Controls, SAP, TrackWise, GMP Regulations, Communication Skills, Problem-Solving Skills, Independent Work

Industry

Staffing and Recruiting

Description

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. Log on now to our website http://www.qrcgroup.com/ to learn more about our services and solutions! Job Description The 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.

Responsibilities

The Senior Engineer provides technical support for Drug Substance manufacturing processes and leads process monitoring activities. They collaborate with cross-functional teams to ensure robust and compliant operations.