Summary of Objective: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: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned.
- 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.
- Proficiency in engineering principles and their application to pharmaceutical manufacturing processes
EDUCATION- 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.
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