Empleos en Pr juncos pr
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Technical Certification on Industrial Mechanic, Electronics, or any related industrial certification, or minimum of 6 months demonstrated proficiency on IDS equipments.Mostrar másÚltima actualización: hace más de 30 días
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Engineer Specialist
BioPharma Consulting JAD GroupJuncos, PR, US Under general supervision, the Engineer Specialist will play a key role in characterizing process optimization strategies and troubleshooting operational issues in the manufacturing, pilot plant, o...Mostrar másÚltima actualización: hace más de 30 días
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Engineer Specialist
BioPharma Consulting JAD GroupJuncos, PR, USHace más de 30 días
Descripción del trabajoExcellent problem-solving and technical skills Strong written and verbal communication skills, including technical report writing Ability to create and deliver basic technical presentations Proficiency in using technology and computer systems to enhance engineering practices Demonstrated ability to self-learn and adapt to new technologies or processes Strong organizational skills and the ability to manage multiple tasks efficiently Bachelor’s or Master’s degree in Engineering (Chemical, Mechanical, Electrical, or a related field) Minimum of 2 years of engineering experience in a pharmaceutical or biotech manufacturing environment Experience working in GMP-regulated environments (manufacturing operations, engineering operations) Familiarity with validation processes and documentation in highly regulated environments Ability to operate specialized laboratory and manufacturing equipment as required Strong understanding of control systems (input, output, control) and their impact on manufacturing processes Experience in troubleshooting equipment such as valves, pumps, and utilities systems Familiarity with drug substance / API operations Experience in equipment startup, troubleshooting, and PLC systems Proven ability to apply engineering principles to resolve technical problems and optimize manufacturing processes 1 year contract with possible extension 12 hours shifts, 48 hours a week
Job Description
Job Description
Under general supervision, the Engineer Specialist will play a key role in characterizing process optimization strategies and troubleshooting operational issues in the manufacturing, pilot plant, or capital projects environments. This position will involve applying basic engineering principles to system modifications, experiments, and / or capital projects. The engineer will collaborate with cross-functional teams to support operational excellence and ensure regulatory compliance in a GMP-regulated environment.
Responsibilities
- Troubleshoot and resolve a variety of technical problems of moderate complexity within manufacturing and production systems.
- Serve as a technical expert to equipment and systems, actively supporting daily operations and resolving complex issues as required.
- Routinely audit operational performance, ensuring compliance with regulatory standards and identifying areas for system improvement.
- Work closely with manufacturing, maintenance, research, process development, utilities, facilities, quality assurance, and validation teams to recommend and implement system modifications.
- Analyze equipment-related problems, understand the variables that impact processes, and propose solutions to resolve issues effectively.
- Work under the direct supervision of project managers to complete design, engineering, and construction projects within specified schedules and budget constraints.
- Collaborate with consultants, architects, and engineering firms on the development of design documents and equipment specifications.
- Obtain, review, and critique quotes for equipment modifications or installations, ensuring feasibility and cost-effectiveness.
- Generate project cost estimates and schedules, providing detailed and accurate documentation to support project execution.
- Ensure compliance with GMP, GLP, and other regulatory requirements in all engineering processes and activities.
- Provide support for validation activities, including writing validation protocols and assisting in validation execution.
- Contribute to equipment startup and troubleshooting, particularly in relation to control systems, failure modes, and operational performance.
Skills & Competencies
Requirements
Qualifications
Preferred Qualifications
Benefits