Project Engineer

Endo; Village of Hobart (NY); Presencial; USD 84.000 - 114.000; Jornada completa

Descripción de la vacante

Par Health is seeking a Project Engineer to manage capital expenditure projects in a pharmaceutical manufacturing setting, ensuring safety, on-time delivery, budget adherence, and regulatory compliance.

The role requires leading end-to-end CAPEX initiatives, coordinating engineering, quality, validation, and external vendors while maintaining robust documentation and support for validation efforts.

Formación

• Bachelor's degree in Engineering (Chemical, Mechanical, Electrical or related discipline).
• 1-3+ years experience in manufacturing environments, pharmaceutical or regulated preferred.
• Proven CAPEX project management experience.
• Strong GMP/regulatory knowledge.
• PM certification (PMP or equivalent).

Responsabilidades

• Lead end-to-end execution of CAPEX projects including planning, design, procurement, construction, and commissioning.
• Develop project scopes, budgets, schedules, and resource plans.
• Coordinate cross-functional teams including engineering, quality, validation, manufacturing, and external vendors.
• Ensure compliance with cGMP, FDA, EMA, and other regulatory requirements.
• Oversee equipment selection, installation, and qualification (IQ/OQ/PQ).
• Manage contractors, suppliers, and construction activities on-site.
• Perform risk assessments and implement mitigation strategies.
• Track project performance and provide regular status updates to stakeholders.
• Drive continuous improvement and cost optimization in project execution.
• Ensure proper documentation and support validation efforts.

Conocimientos

CAPEX management

GMP knowledge

PM certification

Educación

Bachelor's in Engineering

Herramientas

CAD/CAM

Descripción del empleo

Why Us?

At Par Health, we believe great healthcare is built on getting the essentials right. We're looking for passionate, talented individuals who share our commitment to improving lives. With a global workforce, we lead with pride and purpose-prioritizing quality and safety while fostering a culture of continuous improvement, accountability, and teamwork. Elevating the Essentials isn't just our tagline, it's the higher standard we live by every day.

Job Description Summary

The Project Engineer is responsible for managing and executing capital expenditure projects within a pharmaceutical manufacturing environment. This role ensures projects are delivered safely, on time, within budget, and in compliance with regulatory standards (GMP, FDA, etc.).

Job Description

ESSENTAIL FUNCTIONS:

• Lead end-to-end execution of CAPEX projects including planning, design, procurement, construction, and commissioning.
• Develop project scopes, budgets, schedules, and resource plans.
• Coordinate cross-functional teams including engineering, quality, validation, manufacturing, and external vendors.
• Ensure compliance with cGMP, FDA, EMA, and other regulatory requirements.
• Oversee equipment selection, installation, and qualification (IQ/OQ/PQ).
• Manage contractors, suppliers, and construction activities on-site.
• Perform risk assessments and implement mitigation strategies.
• Track project performance and provide regular status updates to stakeholders.
• Drive continuous improvement and cost optimization in project execution.
• Ensure proper documentation and support validation efforts.

DEPARTMENT SPECIFIC/NON-ESSENTIAL FUNCTIONS:

• Perform additional duties and special projects as assigned by department leadership.
• Support continuous improvement initiatives within the department.
• Assist with cross-functional projects and interdepartmental coordination.
• Participate in training sessions, workshops, and professional development activities.
• Maintain departmental documentation, reports, and records as required.
• Provide backup support for other team members during absences or peak workloads.
• Contribute to process optimization and efficiency improvements.
• Attend meetings and provide input on departmental goals and performance.
• Support implementation of new tools, systems, or procedures within the department.
• Ensure compliance with company policies and relevant regulatory requirements when performing assigned tasks.

MINIMUM REQUIREMENTS:

Education:
Bachelor's Degree in Engineering (Chemical, Mechanical, Electrical or related discipline)

Experience:
1-3+ years experience in manufacturing environments. (Pharmaceutical or regulated manufacturing preferred)

Preferred Skills/Qualifications:

• Proven experience managing CAPEX projects.
• Strong knowledge of GMP and regulatory requirements.
• Project Management certification (PMP or equivalent )

Other Skills:

• Strong project management and organizational skills.
• Excellent communication and stakeholder management abilities.
• Technical expertise in process equipment and facility systems.
• Problem-solving mindset with attention to detail.
• Ability to manage multiple projects simultaneously.

Competencies:

• CAD/CAM Proficiency
• Problem Solving & Root Cause Analys
• Continuous Improvement (Lean/Six Sigma)
• Automation & Industry 4.0 Awareness

WORKING CONDITIONS:

• Position will work both an office environment and in a manufacturing plant environment.
• Must be able to wear the required Personal Protective Equipment (PPE) out on the plant site as deemed necessary by EH&S.
• Occasional travel required.

The expected base pay range for this position is $83,895 -$113,505. Please note that base pay offered may vary depending on factors including job-related knowledge, skills, and experience.

EEO Statement:

We comply with all applicable federal, state, and local laws prohibiting discrimination and harassment, and provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status, or genetic information, or any other classification protected by federal, state or local law. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.