
Process Engineer
hace 3 semanas
We are seeking a Process Engineer with a background in Mechanical Engineering, Biotechnology, or Chemical Engineering to support process optimization, troubleshooting, and system modifications in a pharmaceutical/biotech manufacturing environment.
The ideal candidate will apply engineering principles to enhance operations, evaluate system performance, and collaborate with cross-functional teams to drive process improvements.
Key Responsibilities: Provide technical solutions to moderate engineering problems in manufacturing, pilot plants, or capital projects.
Evaluate, select, and apply standard engineering techniques to resolve operational challenges.
Conduct troubleshooting and root cause analysis for equipment and systems to maintain performance and compliance.
Collaborate with research, manufacturing, maintenance, utilities, quality assurance, and validation teams to develop system modifications and improvements.
Audit operational performance and regulatory compliance of manufacturing systems and processes.
Work under the supervision of project managers to support design, engineering, and construction projects within budget and schedule.
Collaborate with consultants, architects, and engineering firms on standard design documentation.
Obtain and review quotes for equipment modifications or installations.
Assist in developing cost estimates, schedules, and project planning.
Ensure documentation meets GMP/GLP requirements in a highly regulated environment.
Support validation processes and execution of validation protocols.
Assist in technical report writing, protocol development, and regulatory compliance assessments.
Requirements Qualifications: Master's Degree OR Bachelor's Degree in Engineering (Mechanical, Biotechnology, or Chemical) with 2+ years of Engineering experience.
Preferred Qualifications & Skills: Pharmaceutical or biotech manufacturing experience.
Familiarity with validation processes and protocol execution.
Ability to interpret and apply GLP/GMP regulations.
Skilled in troubleshooting and problem-solving within a regulated environment.
Strong technical writing and documentation skills.
Experience operating specialized laboratory equipment and process control systems.
Proficiency in engineering design, equipment validation, and process improvements.
Strong analytical, organizational, and communication skills.
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