Project Engineer II

About the role

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

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