
Engineer
hace 4 semanas
Under general supervision, the Operations/Design Engineer is responsible for providing solutions to operational and engineering issues in the manufacturing, pilot plant, or capital projects environment.
The role involves applying basic engineering principles to design, modify, and implement system changes, troubleshoot operational problems, and optimize processes.
The engineer will work on both operational troubleshooting and design engineering projects, often interacting with various departments such as research, manufacturing, maintenance, and quality assurance.
This position requires a hands-on approach to equipment optimization, system design, and ensuring compliance with regulatory standards.
Key Responsibilities: Technical Problem Solving & Operations Engineering: Provide solutions to a variety of moderate scope technical problems, applying standard engineering techniques and procedures.
Investigate operational issues and design experiments or modifications to resolve them.
Audit the operational performance and regulatory compliance of equipment systems of significant complexity.
Serve as a technical expert for troubleshooting operations and actively assist in daily operations to meet schedules or resolve complex issues.
Work with cross-functional teams (research, manufacturing, quality assurance, etc.)
to develop recommendations for system modifications.
Design Engineering: Under direct supervision, assist in completing design, engineering, and construction projects within schedule and budget constraints.
Collaborate with consultants, architects, and engineering firms to develop standard design documents and technical specifications.
Obtain and evaluate quotes for equipment modifications or installations.
Generate project cost estimates and schedules for minor to moderate scope projects.
Support the design and implementation of system improvements.
Equipment and Systems Optimization: Lead initiatives to enhance system reliability, focusing on equipment availability, downtime reduction, and maintenance optimization.
Collaborate with engineering teams to determine the best maintenance strategy for manufacturing equipment.
Develop and track equipment performance metrics (e.g., availability, downtime) and identify improvement opportunities.
Act as Subject Matter Expert (SME) for system design, maintenance, and compliance operations.
Support troubleshooting efforts and process deviations for equipment issues within the assigned functional area.
Regulatory Compliance and Documentation: Ensure that all engineering work adheres to GMP, GLP, and other applicable regulatory standards.
Assist in the creation and review of technical documentation, including validation protocols and reports.
Participate in validation protocol execution and support compliance with regulatory requirements.
Define, implement, and manage corrective actions (CAPAs) related to equipment within the area of expertise.
Safety & Environmental Compliance: Contribute to Environmental, Health, and Safety (EHS) compliance within engineering and operational activities.
Support the implementation of safety measures in both engineering projects and operational processes.
Preferred Experience/Skills: Working knowledge of pharmaceutical/biotech processes and validation practices.
Familiarity with documentation in a highly regulated environment.
Ability to operate specialized laboratory equipment and computer systems.
Experience with CMMS systems for manufacturing equipment (work orders, PM strategy, spare parts, etc.).
Ability to interpret and apply GMP, GLP, and regulatory standards.
Strong technical problem-solving and applied engineering skills.
Experience in developing and implementing equipment performance metrics (availability, downtime, etc.).
Ability to write basic technical reports and perform technical presentations.
Knowledge of validation protocol writing and execution.
Strong verbal and written communication skills.
Requirements Qualifications: Master's degree or in Engineering (Mechanical, Electrical, Chemical, etc.)
with a minimum of 2 years of engineering experience.
Bachelor's degree in Engineering (Mechanical, Electrical, Chemical, etc.)
with a minimum of 2 years of engineering experience.
Additional Attributes (Preferred Qualifications): Experience with equipment ownership and maintenance in CMMS systems.
Ability to drive change and implement improvements in equipment reliability and performance.
Expertise in managing equipment-related deviations and CAPAs.
Benefits Administrative Shift
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