PDS Tech, Inc. is seeking a Plant PCT Engineer, in Berkeley, CA.
Plant Engineering department supports production with engineering related activities associated with equipment, utilities, instrumentation and facility repair/improvement/maintenance.
Technical subject matter expert accountable for planning, coordination, and execution of technical activities needed to support manufacturing operations.
POSITION DUTIES & RESPONSIBILITIES
• Plan, direct, coordinate and execute activities concerned with design, construction, modification, and maintenance of equipment, machinery, and facilities.
• Estimate the production cost for products the facility makes. Evaluate and implement cost-saving methods. Update management on estimated costs of changes in product design so appropriate action can be taken.
• Subject matter expert to advise vendors and management about product specifications and plant capabilities.
• Direct maintenance of production buildings and coordinate requirements for new designs, surveys, and maintenance schedules for equipment and machinery.
• Optimize production processes and logistics with regard to safety, environment, cost, quality and regulatory requirements.
• Provide the necessary technical expertise for troubleshooting and resolving problems with Production Unit processes and equipment; collect, analyze, and report equipment downtime information; ensure resolution of critical equipment items. Perform Risk Assessments and resolution of risk analysis.
• Develop, review, and implement recommendations to improve reliability of infrastructure and production systems. Maintain the Calibration, Maintenance and Safety procedures in defined area of responsibility. Develop specification and strategy of spare parts to meet reliability objectives
- Minimum Education BS Degree in Chemical, Electrical, Mechanical Engineering or related discipline
- B.S. 8+ years
- M.S. 4+ years
Skill & Competency Requirements:
• Knowledge and hands-on experience with pharmaceutical manufacturing processes, including equipment, utilities, and facilities, cGMP compliance, high purity water systems, clean room HVAC systems, process instrumentation and control systems, etc., are required.
• Experience with Process Control Systems, including DCS, PLC, instrumentation and low voltage electrical systems
• Experience with FAT, SAT, Commissioning and Qualification, including hands on experience starting-up and running new equipment, resolving technical equipment issues, developing turn-over packages.
• Experience with regulatory and cGMP requirements for pharmaceutical manufacturing
• Demonstrated ability to troubleshoot complex equipment / systems and supporting utility services
• Working knowledge for high and low voltage (up to 12.4 kV) / low (?480 V)) electrical distribution switchgear, motor control including solid state systems and back-up power generation systems and equipment life cycle management: how they work, how they support the production of biopharma products, and how they are maintained in a qualified safe state. ·
• Basic understanding and familiarity with electrical drawings including one and three-line diagrams, electrical schematics, electrical wiring diagrams and P&IDs.
• Basic understanding and desire to learn in depth of electrical safety practices and procedures including NFPA70E and OSHA regulations. Familiar with electrical codes and standards including NEC, IEC and IEEE.