Plant Engineer II

Our investment is in People who make an impact, drive progress and create a better tomorrow. 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.

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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Requirements

• 4+ years’ experience with GMP, ISO, and/or an FDA-regulated environment is required.
• Proficiency in engineering principles and their application to pharmaceutical manufacturing processes.
• Bachelor's degree in Engineering, Science, or a related field.

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.