Summary

As a Project Engineer specializing in capital projects within the life science industry, specifically pharmaceuticals and cell & gene therapies, you will play a crucial role in the planning, design, and execution of engineering projects. With a minimum of 4 years of experience, you will collaborate with the client and in cross-functional teams to ensure successful project delivery, adherence to industry regulations, and achievement of project objectives. Your expertise in engineering principles and knowledge of the life science industry will contribute to the overall success of capital projects.

Job Functions, Essential Duties & Responsibilities

Project Planning and Strategy:

• Collaborate with internal stakeholders, including engineering, R&D, and manufacturing teams, to define project goals, scope, and deliverables.
• Develop project plans, engineering specifications, and detailed designs for capital projects, considering safety, quality, and regulatory requirements.
• Conduct feasibility studies and cost-benefit analyses to evaluate project viability and recommend solutions.

Project Execution and Management:

• Coordinate and manage tactical phases of the project lifecycle, including procurement, construction, commissioning, and qualification/validation activities.
• Ensure compliance with applicable regulations and standards, such as FDA, cGMP, and industry best practices.
• Monitor project progress, track key milestones, and manage project timelines and budgets.
• Identify and mitigate project risks, resolve issues, and communicate updates to stakeholders.

Cross-functional Collaboration:

• Collaborate with internal teams, external vendors, and contractors to align project objectives and ensure effective execution.
• Serve as a technical resource, providing guidance and support to team members and stakeholders.
• Foster strong working relationships with key stakeholders, such as regulatory agencies, engineering consultants, and equipment suppliers.

Job Functions, Essential Duties & Responsibilities

Documentation and Reporting:

• Prepare and maintain project documentation, including engineering drawings, technical specifications, and project reports.
• Generate progress reports, highlighting project status, key metrics, and any deviations from planned objectives.
• Ensure accurate and timely completion of project documentation, including change control and deviation management.

Continuous Improvement:

• Identify opportunities for process optimization, cost reduction, and efficiency improvements within capital projects.
• Implement lessons learned from previous projects to enhance future project outcomes.
• Stay up to date with industry trends, technological advancements, and regulatory changes relevant to the life science industry.

Qualifications, Education and/or Experience

• Bachelor's degree in engineering (e.g., chemical, mechanical, biomedical) or a related field. Advanced degrees or certifications are a plus.
• Minimum of 4 years of experience in project engineering or related roles within the life science industry, preferably with exposure to capital projects in pharmaceuticals and cell & gene therapies.

Skill Sets, Core Competencies

• Ability to address client needs, build trust and deliver on commitments.
• Excellent communication, collaboration, and problem-solving skills.
• Ability to work effectively with cross-functional teams and stakeholders at various levels.
• Strong knowledge of engineering principles, standards, and practices in the life science industry.
• Familiarity with regulatory requirements, such as FDA, cGMP, and industry-specific guidelines.
• Experience in project management methodologies, including planning, execution, and risk management.
• Proficiency in engineering software tools and project management software.
• Excellent communication, collaboration, and problem-solving skills.
• Ability to work effectively in cross-functional teams and manage multiple projects simultaneously.
• Results oriented approach to departmental performance.
• Adaptable to managing change.
• Ability to navigate and thrive in a fast-paced, dynamic work environment.

Work Environment, Physical Demands

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.