Plant Engineer II

Summary

As a Plant Engineer II, you will play a key role in optimizing and maintaining manufacturing equipment to ensure efficient and compliant pharmaceutical fill-finish production. This position requires a skilled engineer with understanding of equipment design, troubleshooting, and process improvement. The Plant Engineer II will work closely with cross-functional teams to support continuous improvement initiatives and contribute to the success of site projects while working closely with experienced senior engineers.

Essential Duties and Responsibilities

• Lead the design and specification of manufacturing equipment, ensuring compliance with project requirements.
• Coordinate the installation, commissioning, and validation of new equipment.
• Troubleshoot and resolve equipment-related issues, working closely with cross-functional teams.
• Develop and implement preventive maintenance programs for critical equipment.
• Contribute to the continuous improvement of manufacturing processes through equipment upgrades and modifications.
• Mentor and guide entry-level engineers in equipment-related tasks.

Equipment Design and Optimization

• Collaborate with the engineering team to design, specify, and optimize manufacturing equipment for pharmaceutical production.
• Conduct feasibility studies and provide technical input to ensure equipment meets project requirements.

Process Improvement

• Identify opportunities for process optimization, efficiency gains, and cost reduction within the manufacturing environment.
• Implement and oversee continuous improvement initiatives to enhance equipment performance and reliability.

Equipment Qualification and Validation

• Develop and execute equipment qualification protocols and validation procedures in compliance with industry regulations.
• Ensure equipment is qualified for intended use and meets regulatory standards.

Troubleshooting and Maintenance

• Provide technical support for equipment-related issues, troubleshoot problems, and implement corrective actions.
• Collaborate with maintenance teams to develop and execute preventive maintenance plans for manufacturing equipment.

Documentation and Compliance

• Generate and maintain accurate and comprehensive documentation related to equipment specifications, processes, and validation activities.
• Ensure adherence to regulatory requirements and quality standards in all equipment-related activities.

Safety

• Ensure contractor compliance with EH&S policies and procedures, including Hot Work and Lock Out Tag Out; uphold all safety procedures and safe practices.
• Inspect contractor's work to ensure that safe work practices and standard operating procedures are followed.

Qualifications

Experience: 4+ years' experience with GMP, ISO, and/or an FDA-regulated environment is required.

Education: Bachelor's degree in Engineering, Science, or a related field.

Required Qualities

• Strong project management skills
• Knowledge of regulatory requirements and industry quality standards
• Support initiatives to completion
• Excellent communication and interpersonal skills with the ability to work collaboratively across departments
• Detail oriented with problem-solving capabilities and able to implement innovative ideas
• Assertive, self-directed, and results-oriented
• Strong commitment to conducting PCI business according to the highest legal and ethical standards and to continually pursue excellence in the manufacturing and delivery of PCI products and services.
• Resilient, can quickly move forward despite challenges, thrives on challenges to improve skills and abilities
• Must be able to work as a self-starter and handle multiple priorities in a dynamic cross-functional team-based environment.