The Role
Lead engineering efforts for process optimization, troubleshooting, and system/facility modifications in pharmaceutical manufacturing. Coordinate cross-functional teams, manage consultants and budgets, develop policies and protocols, and supervise engineers/technicians. Apply advanced engineering techniques, validation/documentation, and inspection technology expertise for parenteral and glass container equipment.
Summary Generated by Built In
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:
Qualifications:
Responsibilities:
- Independently provides and/or directs the characterization of process optimization strategies and/or troubleshooting of operational issues in the operations, manufacturing, pilot plant or capital projects environment
- Work with research, manufacturing, process development, utilities, facilities, quality assurance and validation departments in developing requirements and recommendations for large and/or highly complex system/facility modifications.
- Work with project managers to complete design and engineering projects within schedule, budget and quality constraints.
- Coordinate the work of consultants, architects and engineering firms on development of standard design documents.
- Develop departmental budgets or project budgets encompassing multiple disciplines for area within project or entirety of smaller project
- Develop engineering policies and procedures that affect multiple organizational units.
- Supervise, coordinate and review work of a small staff of engineers, associates and/or technicians on an ongoing basis as well as on a project basis.
- Employ advanced engineering techniques and/or modifications of advanced techniques within area of engineering expertise.
- Apply knowledge of engineering principles and practices outside of area of discipline expertise to broad variety of assignments in related fields.
- Serves as a peer-recognized engineering technology specialist in at least one area, with overall responsibility for determining methodologies in that area.
Qualifications:
- Bachelor’s degree in mechanical, electrical or industrial engineering preferred
- +4 years of Engineering experience
- Maintenance knowledge and experience with automated and manual inspection equipment operation.
- Technical knowledge of inspection technologies for parenteral and glass containers
- Proven experience applying engineering principles to system modifications, process improvements, and project execution.
- Strong knowledge of equipment reliability, performance improvement, and engineering best practices.
- Demonstrated ability to lead and provide technical guidance to cross-functional teams, including Mechanics, Automation Technicians, and IS personnel.
- Basic knowledge with validation and documentation processes in a highly regulated environment.
- Protocol Development and execution requirements.
- Technical writing and verbal communication on English and Spanish
- First Shift - 6:30am-2:30pm.
Skills Required
- Bachelor's degree in mechanical, electrical or industrial engineering
- +4 years of engineering experience
- Maintenance knowledge and experience with automated and manual inspection equipment operation
- Technical knowledge of inspection technologies for parenteral and glass containers
- Proven experience applying engineering principles to system modifications, process improvements, and project execution
- Strong knowledge of equipment reliability, performance improvement, and engineering best practices
- Demonstrated ability to lead and provide technical guidance to cross-functional teams (Mechanics, Automation Technicians, IS personnel)
- Basic knowledge of validation and documentation processes in a regulated environment
- Protocol development and execution experience
- Technical writing and verbal communication in English and Spanish
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The Company
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
