Project Engineer II

PCI Pharma Services•Bedford, NH

18h

About The Position

The Project Engineer II leads and manages complex engineering projects from initiation through completion, developing project-management strategies that align with organizational goals. The role works with clients and cross-functional teams to define and deliver projects, optimize processes, provide technical guidance, and resolve engineering issues. It also supports manufacturing-process design and optimization while ensuring efficiency, scalability, quality, regulatory compliance, and a safe workplace for contractors and PCI employees. The position develops project scopes, objectives, deliverables, schedules, and budgets; monitors progress and risks; and implements solutions to keep work on track. It oversees contractor performance and compliance with contract terms, investigates and resolves problems, approves or withholds invoices, and manages work orders and related documentation. The role collaborates with R&D, manufacturing, quality assurance, and regulatory affairs, and helps conduct risk assessments and implement corrective actions. It ensures contractors follow EH&S policies and procedures, including Hot Work and Lock Out Tag Out, and inspects work for compliance with safe practices and standard operating procedures.

Requirements

Bachelor’s degree in engineering, science, or a related field.
3–5 years of experience with GMP, ISO, and/or an FDA-regulated environment.
Proven project-management experience, preferably in the pharmaceutical or biotechnology industries.
Strong understanding of engineering principles and their application to pharmaceutical manufacturing processes.
Proficiency in project-management methodologies and tools.
Ability to drive initiatives to completion.
Excellent communication and interpersonal skills, including the ability to collaborate across departments.
Detail-oriented, with strong analytical and problem-solving capabilities.
Assertive, self-directed, and results-oriented.
Commitment to conducting PCI Pharma Services business according to high legal and ethical standards and pursuing excellence in manufacturing and delivery of its products and services.
Resilience and ability to move forward through challenges, with a desire to improve skills and abilities.
Ability to work as a self-starter and handle multiple priorities in a dynamic, cross-functional, team-based environment.

Nice To Haves

Project Management Professional (PMP) certification.

Responsibilities

Lead and manage complex engineering projects from initiation to completion.
Develop and implement project-management strategies aligned with organizational goals.
Collaborate with clients and internal teams to define project scopes, objectives, and deliverables.
Develop detailed project plans, schedules, and budgets.
Monitor project progress, identify risks, and implement proactive solutions.
Monitor contractor performance for compliance with contract terms and conditions; investigate, document, and resolve problems.
Approve or withhold payment of invoices and manage the execution, evaluation, and closing of work orders and related documentation.
Work with R&D, manufacturing, quality assurance, and regulatory affairs to ensure seamless project integration.
Foster communication and collaboration among team members.
Apply engineering principles to design and optimize manufacturing processes for efficiency, scalability, and compliance with industry standards.
Troubleshoot and resolve technical issues during the project lifecycle.
Implement and follow quality-assurance protocols for product quality and regulatory compliance.
Collaborate with quality assurance on risk assessments and corrective actions.
Ensure contractor compliance with EH&S policies and procedures, including Hot Work and Lock Out Tag Out.
Inspect contractor work to ensure safe work practices and standard operating procedures are followed.
Ensure a safe workplace for contractors and PCI employees.
Provide technical leadership and guidance to project teams.
Interface with clients and external partners to understand and meet project requirements.
Evaluate and optimize project processes to enhance efficiency.