Process Engineer

Process Engineer - Contract - Gaithersburg, MD

Proclinical is seeking a Site Process Engineer to join the Engineering team.

Primary Responsibilities:

This role will focus on equipment functionality and operational requirements within specific process flows, as well as the design, optimization, and implementation of Manufacturing and GxP Laboratory equipment. The successful candidate will collaborate closely with various teams to ensure user requirements and optimal function of all Manufacturing, Laboratory, and Building Space criteria.

Skills & Requirements:

• Bachelor's degree in Chemical Engineering or another related field.
• 0-2 years of experience in the design and construction of processing equipment within a manufacturing plant environment, preferably within a biotechnology or pharmaceutical company.
• Excellent problem-solving skills.
• Knowledge of process and utility systems.
• Strong organisational skills.

The Process Engineer's responsibilities will be:

• Create and maintain Process Flow Diagrams, Risk Assessments, Asset Standardization, and Master Specification Sheets.
• Support the evaluation, selection, and recommendation of process and laboratory equipment for Phase 1 and 2 Clinical Manufacturing of Drug Substance and Drug Product.
• Maintain OEM Files, including Equipment Turnover Packages, O&M Manuals, and Drawings.
• Perform and deliver specific engineering project tasks as necessary.
• Represent the F&E team during Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT) activities.
• Conduct Front-End Loading (FEL) and feasibility studies of equipment used in GMP and cGLP applications.
• Troubleshoot processes during startup of new and existing facilities and process/laboratory equipment.
• Analyze and upgrade process and utility systems as needed (e.g., Autoclaves, WFI, RODI, HVAC, CCA, steam generation, Bioreactors, Incubators, Centrifugation, Chromatography, Filtration, Temperature control units, Cell counters, HPLC's).

Compensation:

• $30 to $35 per hour

If you are having difficulty in applying or if you have any questions, please contact Jackie Cerchio at j.cerchio@proclinical.com

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.