Project Engineer II

PCI NH Lyophilization Services of New England; Bedford (NH); On-site; USD 110,000 - 140,000; Full time

Job summary

PCI Pharma Services seeks an experienced Engineering Project Manager in New Hampshire to lead complex manufacturing projects from initiation to completion. You will develop detailed plans, schedules, and budgets while coordinating cross-functional teams across R&D, manufacturing, quality assurance, and regulatory affairs.

The role requires a Bachelor’s degree in engineering, 3–5 years’ GMP/ISO/FDA experience, and strong leadership and communication skills.

Qualifications

• Bachelor’s degree in engineering, science, or related field.
• PMP certification is a plus.
• 3–5 years’ experience with GMP, ISO, and/or FDA-regulated environments.
• Proven experience in project management in pharmaceutical/biotech industries.
• Strong understanding of engineering principles in manufacturing processes.

Responsibilities

• Lead and manage complex engineering projects from initiation to completion.
• Develop and implement project management strategies aligned with goals.
• Collaborate with cross-functional teams to ensure successful outcomes.
• Evaluate and optimize project processes to enhance efficiency.
• Provide technical leadership to project teams.
• Interface with clients and external partners to meet requirements.

Skills

Project management

Leadership

Communication

Analytical thinking

Self-direction

Ethical standards

Education

Bachelor's degree in engineering

PMP certification (a plus)

Tools

PM software

Job description

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.

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 and manage complex engineering projects from initiation to completion.
• Develop and implement project management strategies aligned with organizational goals.
• Collaborate with cross-functional teams to ensure successful project outcomes.
• Evaluate and optimize project processes to enhance efficiency.
• Provide technical leadership and guidance to project teams.
• Interface with clients and external partners to understand and meet project requirements.
• Ensure a safe workplace for contractors and PCI employees.

Project Planning and Execution

• Collaborate with clients and internal teams to define project scopes, objectives, and deliverables.
• Develop detailed project plans, schedules, and budgets to ensure successful project execution.
• Monitor project progress, identify potential risks, and implement proactive solutions to keep projects on track.
• Monitor contractor's performance for compliance with contract terms and conditions; investigates, documents and/or resolves problems.
• Approve invoices for payment or withholds payment; manage the execution, evaluation and closing of work orders and appropriate documentation.

Cross-Functional Collaboration

• Work closely with cross-functional teams, including R&D, manufacturing, quality assurance, and regulatory affairs, to ensure seamless project integration.
• Foster effective communication and collaboration among team members to optimize project outcomes.

Engineering Expertise

• Apply engineering principles to design and optimize manufacturing processes, ensuring efficiency, scalability, and compliance with industry standards.
• Troubleshoot and resolve technical issues that may arise during the project lifecycle.

Quality Assurance

• Implement and adhere to quality assurance protocols to ensure the highest standards of product quality and regulatory compliance.
• Collaborate with the quality assurance team to conduct risk assessments and implement corrective actions as needed.

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

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.

Education

Bachelor’s degree in engineering, Science, or a related field Project Management Professional (PMP) certification is a plus

Experience

3-5 years’ experience with GMP, ISO, and/or an FDA-regulated environment is required. Proven experience in project management, preferably in the pharmaceutical or biotechnology industries. Strong understanding of engineering principles and their application to pharmaceutical manufacturing processes.

Qualities

• Proficient in project management methodologies and tools
• Ability to drive initiatives to completion
• Excellent communication and interpersonal skills with the ability to work collaboratively across departments
• Detail oriented with strong analytical and problem-solving capabilities
• Assertive, self-directed, and results-oriented
• Strong commitment to conducting PCI PHARMA SERVICES business according to the highest legal and ethical standards and to continually pursue excellence in the manufacturing and delivery of PCI PHARMA SERVICES 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 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, Equity and Inclusion 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.

Why Work for PCI Pharma Services

At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don’t say no, we figure out how.