ATL01-030625_Project Manager –Engineering, Construction & Validation_ IN

Validation & Engineering Group, Inc.; Bloomington (IN); On-site; USD 80,000 - 100,000; Full time

Job summary

An established industry player is seeking a dynamic Project Manager to lead critical projects in a regulated manufacturing environment. This role involves overseeing the entire project lifecycle, from construction and installation through to commissioning, qualification, and final validation. The ideal candidate will ensure that all deliverables meet client expectations while maintaining compliance with cGMP and FDA regulations. This is a fantastic opportunity for a proactive leader who thrives in a fast-paced environment and is committed to excellence. Join a dedicated team that values innovation and quality in the pharmaceutical and biotechnology sectors.

Qualifications

• 10+ years of project management experience in regulated environments.
• Strong knowledge of cGMP and FDA regulations.

Responsibilities

• Oversee project lifecycle from construction to validation.
• Develop project plans, schedules, and budgets.
• Ensure compliance with industry standards and regulations.

Skills

Project Management

Leadership

Communication

Organizational Skills

Risk Management

Education

Bachelor’s degree in engineering or life sciences

Tools

MS Project

Excel

Job description

ATL01-030625_Project Manager – Engineering, Construction & Validation_ IN

4 weeks ago Be among the first 25 applicants

Validation & Engineering Group, Inc. (V&EG) is a leading services supplier providing solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Device industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

We are seeking a talented, dedicated individual committed to working under the highest ethical standards for the following position:

Project Manager – Commissioning, Qualification, and Validation

Position Overview

We are seeking an experienced Project Manager to lead projects from construction and installation through commissioning, qualification (C&Q), and final validation of production, packaging, and utility/facility systems in a regulated manufacturing environment. This role will serve as the single point of accountability for project execution, ensuring all deliverables meet client expectations, timelines, and regulatory requirements while maintaining strict compliance with cGMP and FDA regulations.

Responsibilities

• Oversee the entire project lifecycle, including construction, installation, commissioning, qualification, and validation (CQV) of manufacturing, packaging, and utility/facility systems.
• Develop and implement project master plans, including detailed schedules, resource planning, risk mitigation strategies, and budget oversight.
• Coordinate with contractors, vendors, and cross-functional teams during construction and installation to ensure alignment with CQV requirements.
• Ensure commissioning and qualification activities comply with industry standards, regulatory requirements, and client expectations.
• Lead the execution of risk assessments, design reviews, test matrices, FATs, SATs, commissioning, installation, operational, and performance qualification for all applicable systems.
• Work closely with engineering, automation, IT, quality, and operations teams to ensure facility and equipment readiness.
• Manage project cost, schedule, and scope, ensuring timely and cost-effective delivery.
• Oversee the preparation and quality of CQV documentation, including protocols, reports, and turnover packages.
• Conduct regular meetings and provide progress updates, reports, and metrics to stakeholders.
• Ensure compliance with GMP, EHS, and client standards throughout all project phases.
• Manage project staffing, including hiring, mentoring, and professional development of team members.

Qualifications

• Bachelor’s degree in engineering, life sciences, or a related field.
• Minimum of 10 years of project management experience in pharmaceutical, biotech, or regulated manufacturing environments.
• Strong experience managing projects from construction and installation through commissioning and qualification.
• In-depth knowledge of cGMP, FDA regulations, and industry best practices.
• Proficiency with project management tools and software (e.g., MS Project, Excel).
• PMP certification preferred but not required.
• Excellent leadership, communication, and organizational skills.

This role requires a hands-on, proactive leader capable of overseeing all project phases, ensuring smooth transitions from construction and installation to commissioning, qualification, and final validation.

Seniority level

Mid-Senior level

Employment type

Full-time

Job function

Strategy/Planning and Information Technology