Manufacturing Systems Engineer – 24/7 Pharma ops

Quality Consulting Group, LLC

Juncos (PR)

On-site

USD 80,000 - 115,000

Full time

3 days ago

Be an early applicant

Application generator

Stand out for this role — generate a tailored resume and cover letter in about a minute.

Get past ATS filters

Job summary

Quality Consulting Group, LLC is seeking a talented engineer to join our team operating in Puerto Rico and the USA, working in a world-class pharmaceutical/biotech manufacturing environment. You will apply engineering principles to process and equipment challenges and support continuous improvement.

Responsibilities include troubleshooting, deviations, validations, and collaboration with QA, facilities, and vendors.

Qualifications

Bachelor’s degree in Engineering and 2 years of engineering experience.
Experience as a System Owner in a Manufacturing Management Platform (MMP) environment.
Working knowledge of cGMP in pharmaceutical/biotech manufacturing.
Experience using IBM Maximo CMMS.
Ability to create, process, and manage POs.
Ability to coordinate vendors in a regulated manufacturing environment.
Flexibility to support 24/7 manufacturing operations, including after-hours support.

Responsibilities

Provide solutions to technical problems of moderate scope and complexity.
Evaluate and apply standard engineering techniques under supervision.
Act as a technical expert for process, equipment, and systems during troubleshooting.
Supervise manufacturing processes and contribute to performance improvements.
Collaborate with manufacturing, maintenance, process development, utilities, facilities, QA and validation teams.
Support deviations, equipment qualification, process validation, procedures, training and new product introductions.
Apply engineering principles to design and implement system modifications and capital projects.
Present results and interpretations for operational issues or projects.