Project Engineer II

Project Engineer II

The Project Engineer II leads capital projects that support equipment installations, modifications, and process improvements in a GMP-regulated pharmaceutical manufacturing environment. This role manages projects from concept through startup and qualification, working cross-functionally to deliver safe, compliant, and effective solutions that support operational and business objectives. The position combines project management, technical ownership, and quality leadership to enhance safety, quality, efficiency, and reliability across manufacturing operations.

Responsibilities

• Lead capital projects from initial concept through commissioning, qualification, and operational handover with minimal supervision.
• Define and manage project scope, schedule, budget, and resource requirements to meet agreed objectives.
• Manage vendors, contractors, and procurement activities to ensure successful and timely project delivery.
• Identify and mitigate project risks, proactively driving issue resolution to maintain project timelines and budget.
• Lead design reviews and approve engineering deliverables to ensure alignment with process, safety, and operational requirements.
• Oversee installation, commissioning, startup, and troubleshooting of manufacturing equipment and systems.
• Provide technical guidance on equipment modifications, process optimization, and system improvements to support manufacturing needs.
• Ensure all projects comply with FDA, GMP, and internal quality system requirements throughout the project lifecycle.
• Own change control activities, including initiation, impact assessment, and development of implementation strategies.
• Lead validation and qualification efforts (IQ/OQ/PQ), ensuring systems and equipment are ready for regulatory inspection.
• Ensure all project documentation adheres to ALCOA+ data integrity standards.
• Serve as the primary engineering representative on cross-functional project teams, aligning Manufacturing, Quality, Validation, Maintenance, and EHS stakeholders.
• Provide clear and timely communication on project status, risks, and mitigation strategies to stakeholders.
• Mentor junior engineers and provide guidance to technicians and operators during project execution and equipment startup.
• Drive continuous process improvements that enhance safety, product quality, and operational efficiency.
• Support site initiatives related to right-first-time execution and inspection readiness.
• Identify and implement opportunities for cost savings, capacity increases, and reliability improvements.
• Develop and approve key project documents, including user requirement specifications (URS), functional specifications, protocols, and reports.
• Track and report on project performance metrics such as cost, schedule, and scope, and take corrective actions as needed.
• Lead project closeout activities, including turnover to operations and lessons learned to improve future project execution.
• Collaborate actively across teams, functions, business units, and locations to achieve shared goals and deliver superior service to internal and external customers.
• Demonstrate agility by proactively identifying changes in the environment and leading or embracing change to maintain project and business success.
• Contribute innovative ideas, products, services, or process improvements that introduce new capabilities or significantly enhance existing ones.
• Execute responsibilities with a strong focus on quality, reliability, and operational excellence in alignment with organizational culture and strategy.

Essential Skills

• Bachelor's degree in Engineering, such as Chemical, Mechanical, Biomedical, Industrial, or a related discipline.
• 3–6 years of experience executing capital projects in manufacturing environments.
• 5+ years of experience in a regulated environment or within pharmaceutical or medical device industries.
• Demonstrated experience leading capital projects from concept through commissioning, qualification, and operational handover.
• Proven ability to define and manage project scope, schedule, budget, and resources with minimal supervision.
• Strong project management skills, including risk identification, mitigation, and issue resolution.
• Hands-on experience with manufacturing processes and equipment installation, commissioning, and troubleshooting.
• Knowledge of GMP requirements and experience working in GMP-regulated environments.
• Understanding of FDA and quality system requirements relevant to pharmaceutical manufacturing.
• Experience with validation and qualification activities, including IQ, OQ, and PQ.
• Ability to lead and own change control activities, including impact assessment and implementation planning.
• Familiarity with ALCOA+ data integrity principles and their application to project documentation.
• Strong cross-functional collaboration skills with Manufacturing, Quality, Validation, Maintenance, and EHS teams.
• Ability to mentor junior engineers and support technicians and operators during project execution.
• Proven track record of driving process improvements and supporting continuous improvement initiatives.
• Excellent execution skills with a focus on delivering high-quality results on time and within budget.
• Strong written and verbal communication skills for clear reporting and stakeholder updates.

Additional Skills & Qualifications

• Bachelor's degree in Chemical, Biomedical, or Mechanical Engineering is strongly preferred.
• Experience working specifically in pharmaceutical or other highly regulated manufacturing environments.
• Background in medical device or similar regulated industries is beneficial.
• Experience in project engineering and project coordination within manufacturing settings.
• Exposure to continuous improvement methodologies and tools to enhance safety, quality, and efficiency.
• Ability to think differently and develop innovative solutions, products, services, or processes.
• Service-oriented mindset with the ability to understand internal and external customer needs and deliver value beyond expectations.
• Demonstrated agility in adapting to change and proactively responding to evolving business and regulatory requirements.
• Strong operational focus with experience in production and manufacturing process optimization.
• Comfort working in a dynamic, growth-oriented environment with multiple concurrent projects.

Work Environment

This role operates within large, modern pharmaceutical manufacturing facilities, including a major site in New Hope and another in Michigan. The environment is GMP-regulated and focused on the development and production of topical and inhalable generic prescription products such as creams, foams, mousses, gels, liquids, and inhalable formulations. Team members work in a dynamic, high-growth setting where collaboration across functions and locations is essential. The culture emphasizes honesty, transparency, continuous improvement, and making a meaningful impact on patient access to affordable medicines. Work is performed in a combination of office, technical, and manufacturing floor areas, with regular interaction with engineering, manufacturing, quality, validation, maintenance, and EHS teams, and with vendors and contractors supporting capital projects.

Job Type & Location

This is a Contract to Hire position based out of Minneapolis, MN.

Pay and Benefits

The pay range for this position is $36.00 - $45.00/hr. Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully onsite position in Minneapolis, MN.

Application Deadline

This position is anticipated to close on Aug 28, 2026.