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:
- Under general supervision, provides characterization of process optimization strategies and/or troubleshooting of operational issues in the operations, manufacturing, pilot plant or capital projects environment.
- Applies basic engineering principles to the design and implementation of system modifications, experiments and/or capital projects.
- 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:
- Bachelor's degree in Engineering (Chemical Engineering, Mechanical Engineering, and Electrical engineering fields)
- 2 years of Engineering experience
- Preferably, resource should have experience in GMP-related field (manufacturing operations, engineering operations.
- Resource should be capable of resolving equipment related problems by using technical skills to analyze the condition, understand variables that impact the process, and propose and resolve issue.
- Resource should understand control systems (input, output, control).
- Experience in drug substance/API operations.
- Preferred experience in equipment start up, troubleshooting, PLC.
- Candidate must be able to understand manufacturing equipment, failure modes and troubleshoot equipment (valves, pumps, utilities systems).
- Candidate should be excellent self-learning skills, and use technology to his/her advantage
- 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
- Both Shifts: 5AM TO 5PM & 5PM TO 5AM.
- CANDIDATES MUST BE OPEN TO WORK NIGHT SHIFT
Top Skills
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
