EngineerAs a member of the Clinical Bulk Facilities & Engineering organization, this position serves as the plant engineer and system owner for facility systems and process equipment in a bulk biopharmaceutical manufacturing facility. Responsibilities include providing operational support, troubleshooting, and optimization for assigned equipment; directing and coordinating equipment maintenance to improve reliability; and applying engineering principles to the design and implementation of new equipment.
• Support system reliability and operational optimization efforts. Identify system performance risks (e.g. single point of failure or obsolescence) and implement risk reduction strategies. Lead and execute improvement efforts (including identifying cycle reduction time opportunities, efficiency gains, and yield enhancement opportunities).
• Lead or support technical root cause analysis, incident investigations, and troubleshooting on equipment (mechanical, electrical, instrumentation and control system problems). Previous training and experience is preferred.
• Analyze problems, develop and propose engineering solutions in a scientific manner using data-driven techniques and analyses (e.g. Statistical Process Control, Six Sigma, predictive maintenance analysis, etc.)
• Support new product introductions or new technology introductions by performing engineering assessments, implementing equipment modifications, and supporting engineering runs.
• Responsibilities will include execution of capital projects. This role involves the application of process engineering principles in the design, specification, construction, startup, and validation of process equipment and systems for capital projects of moderate scope and complexity. Candidate should have previous exposure to project engineering processes from initial conceptualization through project turnover to operations.
• Ensures the logical, systematic translation of design requirements and constraints into process equipment/system solutions. Assists with project definition by performing engineering studies and assessments for process equipment systems, clean utilities, and production facility improvements.
• Desired skills include demonstrated ability to translate production processes and user requirements into detailed designs aligned with industry practices; ability to apply standard engineering principles and practices to work assignments; and ability to employ basics techniques within area of engineering expertise.
• Support a safe working environment by complying with all pertinent environmental health/safety practice, rules and regulations.
Basic Qualifications
• Master's degree
OR
• Bachelor's degree & 2 years of directly related experience
OR
• Associate's degree & 6 years of directly related experience
OR
• High school diploma / GED & 8 years of directly related experience
Preferred Qualifications
• Bachelor's degree in Chemical Engineering or Bioengineering preferred
• 3+ years of relevant work experience with 1+ years experience in operations/manufacturing environment
• Direct experience in equipment engineering and troubleshooting with fermentors, bioreactors, centrifuges, chromatography columns and systems, and/or ultrafiltration/diafiltration systems.
• Direct experience with regulated environments (e.g. cGMP, OSHA, EPA, etc.) is critical.
• Hands-on experience with manufacturing process equipment including advanced troubleshooting, reliability and performance improvements, and design optimization.
• Ability to apply advanced and diverse engineering principles to the design and implementation of major system modifications, introduction of new processes, and capital projects. Develop technical solutions to complex problems requiring the regular use of ingenuity and creativity.
• Strong leadership, technical writing, and communication/presentation skills are required.
• Work schedule flexibility as required to support 24/7 operations, requiring occasional after-hours engineering coverage.
• Working knowledge and experience with cGMP procedures and engineering practices on pharmaceutical/biotech production processes, facilities, and equipment. Candidate should be experienced in change control, nonconformances, corrective and preventative actions, and validation practices.
• Experience supporting design and startup engineering directly related to bulk biopharmaceutical production including process equipment and facilities design, procurement, construction, startup, and validation is preferred.
• Must be independent, self-motivated, organized, able to multi-task in project environments, and skilled in communication, facilitation, and collaboration. Individual must be a team player prepared to work in and embrace a team-based culture that relies on collaboration for effective decision-making.
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