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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 objectives.
- Foster an environment of professional growth, collaboration, and excellence within the team.
Special Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee must be physically capable to perform the duties listed below with or without reasonable accommodations which may be made to enable individuals with disabilities to perform the essential functions. - Stationary Position: 3/4 of the day and up.
- Move, Traverse: Up to 1/4 of the day.
- Operate, activate, use, prepare, inspect, or place: None
- Install, place, adjust, apply, measure, use, or signal: Up to 1/4 of the day.
- Ascend/Descend or Work Atop: Up to 1/4 of the day.
- Position self (to) or Move (about or to): Up to 1/4 of the day.
- Communicate or exchange information: 3/4 of the day and up.
- Detect, distinguish, or determine: Up to 1/4 of the day. On an average day, the individual can expect to move and/or transport up to 25 pounds
less than 1/4 of the day.
This position may have the following special vision requirements.
Close Vision Distance Vision Color Vision Peripheral Vision Depth Perception
Ability to focus No Special Vision Requirements
Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The following are some environmental conditions that one may be exposed to on a daily basis and for various lengths of time. * Work is primarily performed at a desk and/or in an office environment. for 3/4 of the day and up.
* The noise level in the work environment is typically, moderate. 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
- 15+ years' people leadership experience with GMP, ISO, and/or an FDA-regulated environment is required.
- Proven ability to drive effective positive change (technical and organizational)
- Project management, preferably in the pharmaceutical or biotechnology industries.
EDUCATION
- Bachelors' degree in Engineering, Science, or a related field (required)
- Masters degree in business (required)
- Project Management Professional (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
#LI-LL1 Join us and be part of building the bridge between life changing therapies and patients. Let's talk future Equal Employment Opportunity (EEO) Statement:
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. At PCI, Diversity, Equity, and Inclusion (DEI) are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.
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PCI Pharma Services
Nov 05, 2024