Process Engineer

hace 4 semanas


Juncos, Puerto Rico Biopharma Consulting Jad Group A tiempo completo

Under general supervision, the Process Engineer provides characterization of process optimization strategies and troubleshooting of operational issues within operations, manufacturing, pilot plant, or capital projects environments.
This role applies basic engineering principles to the design and implementation of system modifications, experiments, and/or capital projects.
The Process Engineer organizes, analyzes, and presents the interpretation of results for operational issues or engineering projects of minor scope and complexity.
General Responsibilities: Provide solutions to a variety of technical problems of moderate scope and complexity.
Under general supervision, evaluate, select, and apply standard engineering techniques and procedures, with assistance given for unusual problems.
Perform assignments with clear and specific objectives, requiring the investigation of a limited number of variables.
Initiate and complete routine technical tasks.
Operations Engineering Responsibilities: Function as a technical expert for equipment or systems regarding troubleshooting operations.
Frequently involved in daily operations to meet schedules or resolve complex problems.
Audit the operational performance and regulatory compliance of a moderate number of equipment items or systems of significant complexity.
Collaborate with research, manufacturing, maintenance, process development, utilities, facilities, quality assurance, and/or validation departments to develop requirements and recommendations for system modifications.
Design Engineering Responsibilities: Work under the direct supervision of project managers to complete design, engineering, and construction projects within schedule and budget constraints.
Collaborate with consultants, architects, and engineering firms on the development of standard design documents.
Obtain and critique quotes for equipment modifications or installations.
Generate rudimentary project cost estimates and schedules.
Key Skills: Ability to resolve equipment-related problems by using technical skills to analyze conditions, understand variables impacting the process, and propose solutions.
Knowledge of control systems (input, output, control) and experience in drug substance/API operations.
Preferred experience in equipment startup, troubleshooting, and PLC.
Ability to understand manufacturing equipment, failure modes, and troubleshoot various equipment types (valves, pumps, utilities systems).
Excellent self-learning skills and the ability to leverage technology for problem-solving and process optimization.
Working knowledge of pharmaceutical/biotech processes.
Ability to operate specialized laboratory equipment and computers as appropriate.
Ability to interpret and apply GLPs and GMPs.
Ability to apply engineering science to production.
Ability to develop solutions to routine technical problems of limited scope.
Requirements Education: Master's degree in Chemical Engineering, Mechanical Engineering, or Electrical Engineering fields with 2 years of experience in GMP related fields OR Bachelor's degree in Chemical Engineering, Mechanical Engineering, or Electrical Engineering fields with 2 + years of experience in GMP related fields Preferred Qualifications: Familiarity with validation processes and documentation in highly regulated environments.
Comprehensive understanding of validation protocol execution requirements.
Demonstrated skills in problem-solving, applied engineering, technical report writing, and verbal communication.\ Demonstrated skills in technical presentations, personal organization, and validation protocol writing.
Strong analytical problem-solving and computer literacy skills.
Benefits 2nd Shift 3rd Shift


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