JT986 - ENGINEER

Juncos, Puerto Rico

Contracted

Biopharmaceutical

Mid Level

QUALITY CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic to join our team. In this role, you’ll work with a highly enthusiastic team, contributing in a world-class manufacturing industry in Puerto Rico & USA.

Responsibilities:

Provide technical engineering support to continuous daily operations by performing troubleshooting activities, process optimization strategies, upgrades, replacements, and modifications to the process or equipment in the manufacturing operations.
Ensure that all operations are accomplished in a compliant manner consistent with current corporate policies, industry standards, and applicable regulatory requirements.
Support non-standard shift manufacturing operations that may nights and weekends.
Function as a technical expert to process, equipment and/or systems during troubleshooting operations and multi-functional discussions.
Routinely supervise manufacturing processes for performance indicators and operations.
Work with manufacturing, maintenance, process development, utilities, facilities, quality assurance and/or validation departments in developing requirements and
recommendations for process and/or system modifications.
Support the execution of manufacturing/quality systems such as deviations, equipment qualification and/or process validation, procedures, training, and new product introductions.
Apply process, operational, scientific expertise, basic compliance knowledge, and analytical and troubleshooting skills to support manufacturing operations.
Organizes, analyzes and presents interpretation of results for operational issues or engineering projects of moderate scope and complexity.
Apply basic engineering principles to the design and implementation of system modifications, experiments and/or capital projects.

Qualifications:

Bachelor’s degree in Engineering, preferably in Mechanical, Electrical and/or Chemical Engineering
Experience with equipment and/or process troubleshooting in a regulated environment.
Knowledge of pharmaceutical/biotech processes and GMP production operations.
Organizational & technical writing skills.
Proficient presentation & communication skills in English and Spanish
Working knowledge of pharmaceutical/biotech processes
Familiarity with validation processes
Familiarity with documentation in a highly regulated environment
Ability to operate specialized laboratory equipment and computers as appropriate.
Ability to interpret and apply GLPs and GMPs
Ability to apply engineering science to production
Non-Standard Shift (12 hour night shift)

Quality Consulting Group, LLC is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.

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