Capital Project Engineer – API Pilot Plant & R&D Facilities

Hi,

My name is Karthik Mutyala, from Stark Pharma Solutions Inc, we are hiring talents for our client. I am working on Sr Capital Project Engineer API Pilot Plant & R&D Facilities position right now. Please send me your updated resume if you have relevant experience and interested in this position. The detailed job description is as follows

Role: Senior Capital Project Engineer API Pilot Plant & R&D Facilities

Location: North Chicago, IL 100% Onsite

Duration: 1-2 years - Based on performance and business needs

Industry: Pharmaceutical / API Manufacturing / R&D

Position Overview

We are seeking an experienced Senior Capital Project Engineer to lead the planning, design, and execution of capital projects supporting API Pilot Plant operations and laboratory facilities within a pharmaceutical R&D environment. This role will oversee projects involving process equipment installations, facility upgrades, and infrastructure improvements while ensuring compliance with engineering, quality, safety, and regulatory standards.

The ideal candidate will possess strong technical expertise in pharmaceutical process systems, capital project execution, and cross-functional leadership, with the ability to manage multiple projects from concept through commissioning and qualification.

Key Responsibilities

• Lead the planning and execution of small-to-medium capital projects (up to $5M) supporting API manufacturing and laboratory operations.
• Manage projects involving new process equipment installations, facility modifications, and infrastructure upgrades.
• Define project scope, schedules, budgets, and resource requirements while ensuring alignment with business objectives.
• Coordinate cross-functional teams including Engineering, Manufacturing, Facilities, Quality, EHS, and external contractors.
• Develop project execution strategies, procurement plans, and cost estimates while maintaining project controls for scope, schedule, and budget.
• Conduct feasibility studies, engineering evaluations, and economic analyses to support project decisions.
• Design and oversee process systems, equipment, utilities, instrumentation, and facility improvements.
• Review and develop engineering deliverables including P&IDs, equipment specifications, process calculations, and technical documentation.
• Ensure compliance with applicable engineering standards, cGMP requirements, environmental regulations, OSHA standards, and building/fire codes.
• Support commissioning, qualification, and validation activities, including User Requirement Specifications (URS), protocol development, and execution.
• Perform risk assessments and implement mitigation strategies to ensure project success.
• Provide regular project updates to stakeholders and senior leadership.
• Drive innovation, continuous improvement, and implementation of emerging technologies within project designs.
  
  

Required Qualifications

• Bachelor s degree in Chemical Engineering, Mechanical Engineering, or a related engineering discipline.
• 10 years of engineering and capital project management experience within pharmaceutical, chemical, API, or related regulated industries.
• Strong knowledge of pharmaceutical process systems, equipment design, and facility engineering.
• Experience developing and reviewing:
• P&IDs
• Process equipment specifications
• Instrumentation and control systems
• Engineering design packages
• Proven experience managing capital projects from concept through construction, commissioning, and startup.
• Experience with project budgeting, cost control, scheduling, procurement, and contractor management.
• Familiarity with commissioning, qualification, and validation (CQV) activities.
• Working knowledge of FDA cGMP regulations, OSHA requirements, environmental regulations, and building codes.
• Strong leadership, communication, and stakeholder management skills.
• Ability to manage multiple projects simultaneously in a fast-paced environment.
  

I am actively connecting with professionals for current and upcoming opportunities. If you are open to exploring new roles or would like to stay informed about relevant positions, please send me your updated resume along with the best number and time to reach you.

Please follow Stark Pharma Solutions on LinkedIn for the latest job updates: https://www.linkedin.com/company/99455976/

Thank you,

Karthik Mutyala

Recruiting Manager

Stark Pharma Solutions Inc

Email: karthik@starkpharma.com

15 Corporate Place S, Suite 350,

Piscataway, New Jersey 08854

www.starkpharma.com