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
Engineer with experience in regulated industry and manufacturing equipment CMMS to 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.
Responsibilities:
- Collaborate with Engineering Staff to ensure the best maintenance strategy on manufacturing equipment operations.
- Responsible for enhancing system reliability focusing on equipment availability, downtime reduction and maintenance optimization
- Develop equipment performance metrics (availability, downtime, etc.) with emphasis on identifying equipment performance improvement opportunities.
- Lead the implementation of equipment improvements projects
- SME (Subject Matter Expert) for systems regarding design, maintenance and point of contact during compliance operations.
- Support equipment troubleshooting within the functional area or in the scope of technical expertise.
- Support deviation process and define, Implement and own CAPAs associated to equipment within area of expertise Drives Environmental, Health and Safety compliance within the organization
Qualifications
- Masters or Bachelor’s in Engineering + 2 years of Engineering experience (Mechanical, Electrical and/or Chemical Engineering).
- Knowledge of pharmaceutical/biotech processes and GMP production operations.
Organizational & technical writing skills. - Experience in reliability and change control
Proficient presentation & communication skills in English and Spanish.
Additional Information
All your information will be kept confidential according to EEO guidelines.
