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:
- Responsible for enhancing system reliability focusing on equipment availability, downtime reduction and maintenance optimization.
- Function as a technical expert to equipment or systems regarding troubleshooting operations.
- Frequently become actively involved in daily operations when required to meet schedules or to resolve complex problems.
- Routinely audit the operational performance and regulatory compliance of a moderate number of equipment items or systems of significant complexity.
- Work with research, manufacturing, maintenance, process development, utilities, facilities, quality assurance and/or validation departments in developing requirements and recommendations for system modifications.
- Work under the direct supervision of project managers to complete design, engineering, and construction projects within schedule and budget constraints.
- Work with consultants, architects and engineering firms on development of standard design documents.
- Obtain and critique quotes for equipment modifications or installations.
- Generate rudimentary project cost estimates and schedules.
Qualifications:
- Master degree OR Bachelor's degree in Engineering & 2 years of Engineering experience
- Manufacturing Equipment ownership at CMMS system (Work orders approval, closing, PM strategy, spare parts' definition/accuracy/updates), reliability and change control assessments and requirements.
- Collaborate with Engineering Staff to ensure the best maintenance strategy on manufacturing equipment operations.
- 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.
- Shift: Monday – Friday 7:30am – 4:30pm
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What We Do
The Quality Consulting Group is a pharmaceutical, biotechnology, food and medical device specialty consultant that supports the manufacturing industry; services are provided in multiple areas including: Regulatory Compliance, Quality Operations, Validation, Manufacturing, Training and Technical Support. Starting, as individual services provider since 2002, Quality Consulting Group has supported clients implementing the latest standards such as Validation Guidance, ICH Guidelines, and Process Excellence and Risk Management tools.
Quality Consulting Group has provided expertise in such areas as: business, operational, quality, regulatory and manufacturing strategies; organizational structures; management controls; manufacturing and quality systems methodologies and practices; compliance programs; and accuracy reviews; FDA, EMEA and other regulatory matter
