Plant Engineer II

## Plant Engineer IIApplylocations:
Bedford, NH, USAtime type:
Full time posted on:
Posted Todayjob requisition :
JR119011

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
** We are PCI.
** Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
** 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.
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* 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.
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* 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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