Senior Manager, Plant & Process Engineering

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 Senior Manager of Plant and Process Engineering 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, commissioning, validation, and optimization of manufacturing facilities and processes to ensure efficient and compliant operations.

The Senior Manager will lead a team of engineers and collaborate with cross-functional teams to drive continuous improvement initiatives and support the company's growth objectives.

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.

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.
• Enhance Engineering processes through innovative thinking to drive efficiency and compliance improvements.
• Establish a harmonized commissioning and qualification process to drive measurable efficiency for both Engineering and Validation organizations at both a local and global level.

Facility Design and Construction :

• Lead the commissioning of new and updated facilities and production lines, ensuring compliance with regulatory requirements and quality standards.
• Collaborate with internal stakeholders and external partners / clients to optimize facility layouts and workflows for maximum efficiency and scalability.

Process Optimization :

• Oversee the optimization of manufacturing processes to improve efficiency, productivity, and quality while reducing costs and cycle times.
• Implement advanced technologies and methodologies to enhance process capabilities and drive innovation.
• Implement and manage as business process owner an electronic tool to create, review, approve, and execute engineering lifecycle, commissioning, and qualification documentation.
• Reduction of contractor support for capital projects with the implementation of the electronic solution.

Regulatory Compliance :

• Ensure compliance with regulatory requirements, industry standards, and good manufacturing practices (GMP) in all plant and process engineering activities.
• Support regulatory and client inspections and audits related to manufacturing facilities and processes, addressing any findings or recommendations as needed.
• Improve audit request response for validation documentation through the use of an electronic solution.
• Review and approve quality related events with a focus on reduction in deviations and reduction in time to close.

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.
• Serve as a key liaison between engineering and other departments to support project execution and resolve technical issues.

Team Development :

• Mentor, coach, and develop engineering staff, fostering a culture of continuous learning, professional growth, and collaboration.
• Build a high-performing team capable of delivering innovative solutions and driving operational excellence in plant and process engineering.

Qualifications : The requirements listed below are representative of the knowledge, skill, and / or ability required for the stated position.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

EXPERIENCE

• 10+ years’ people leadership experience (Master’s degree) with GMP, ISO, and / or an FDA-regulated environment is required.
• 14+ years’ people leadership experience (Bachelor’s degree) with GMP, ISO, and / or an FDA-regulated environment is required.
• Equipment, facility, utility, computer system, and cold chain commissioning and qualification expert (20+ years as individual contributor or people leader).
• Proven ability to drive effective positive change (technical and organizational).
• Project management, preferably in the pharmaceutical or biotechnology industries.
• New construction capital project large scale facility build / expansion experience a must have.
• Global engineering experience supporting multiple sites.

EDUCATION

• Bachelor’s degree in Engineering, Science, or a related field.
• Master’s degree in business (preferred).

QUALITIES

• Excellent leadership skills :
• Communication
• Empathy
• Coaching and Development
• Decision Making
• Conflict Resolution
• Demonstrated leadership experience, including managing engineering teams and leading complex projects.
• Drive performance through the use of well-defined and understood metrics.
• Expert knowledge of regulatory requirements and industry best practices.
• 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.

Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future

Equal Employment Opportunity (EEO) Statement :

For a complete understanding of this opportunity, and what will be required to be a successful applicant, read on.

PCI Pharma Services is an Equal Opportunity / Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

J-18808-Ljbffr