Director of Plant Engineering, Strategic Digital Solutions

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:
The Director of Plant and Process Engineering and Digital Solutions will be responsible for providing strategic leadership and technical expertise in plant and process engineering for the Bedford, NH site. This role involves overseeing the design, construction, and optimization of manufacturing facilities and processes to ensure efficient and compliant operations.  

The Director will be the global lead for the implementation and oversight of the digital electronic solution that will support engineering lifecycle documents, validation documents, GMP forms, and GMP logbooks that are used across the Bedford, NH site as well as rollout and support for the PCI global network.  

The Director will manage a team of engineers and collaborate with cross-functional teams to drive engineering driven continuous improvement initiatives and support the company's growth objectives.  

The Director will be responsible for managing the Engineering Quality Management team 

The Director will be responsible for managing the Engineering capital project team ensuring the timelines and budget are managed and controlled. 

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.
1.    Strategic Leadership:

• Develop and execute strategic plans for plant and process engineering to support the company's objectives and growth initiatives.
• Provide technical leadership and guidance to the engineering team, ensuring alignment with company/site goals and industry best practices.
• Lead the implementation and steady state management of digital solutions that will support engineering lifecycle documents, commissioning, qualification, validation, GMP forms, and GMP logbooks across the Bedford site and globally.
• Collaborate with site and global stakeholders to drive engineering-driven continuous improvement initiatives.

2.    Facility Design and Construction:

• Oversee the design and construction of new and updated manufacturing facilities, ensuring compliance with all regulatory and quality requirements.
• Lead the commissioning and qualification of facilities and production lines, ensuring that project timelines and budgets are met and controlled.
• Manage the Engineering Capital Projects team to ensure projects are delivered on time, within scope, and on budget.

3.    Process Optimization:

• Optimize manufacturing processes to improve efficiency, productivity, and product quality while reducing costs and cycle times.
• Implement advanced technologies and methodologies to enhance process capabilities and drive continuous improvement.

4.    Digital Solutions Implementation:

• Serve as the global lead for implementing and managing electronic solutions that will support engineering lifecycle documents, commissioning, qualification, validation, GMP forms, and GMP logbooks.
• Ensure successful rollout and support of these digital solutions both at the Bedford, NH site and across the PCI global network.
• Continued support of tool post implementation

5.    Regulatory Compliance:

• Ensure the timely and high-quality completion of GMP events, such as deviations, CAPAs, and change controls, to meet site and global metrics.
• Ensure that all plant and process engineering activities comply with regulatory requirements, industry standards, and good manufacturing practices (GMP).
• Support regulatory and client audits, addressing any findings or recommendations to ensure ongoing compliance.

6.    Cross-functional Collaboration:

• Collaborate with cross-functional teams, including Operations, Quality Assurance, MTS, Global Engineering, and site leadership, to ensure seamless integration of plant and process engineering activities.
• Act as a liaison between engineering and other departments to resolve technical issues and ensure successful project execution.

7.    Team Development:

• Manage and develop the Engineering Quality Management team, fostering a culture of continuous improvement and innovation.
• Mentor, coach, and develop engineering staff, creating a high-performing team capable of delivering on the company’s