Commissioning Documentation Lead

Job Description

Job Description

We're ALTEN Technology USA, an engineering company helping clients bring groundbreaking ideas to life—from advancing space exploration and life-saving medical devices to building autonomous electric vehicles. With 3,000+ experts across North America, we partner with leading companies in aerospace, medical devices, robotics, automotive, commercial vehicles, EVs, rail, and more.

As part of the global ALTEN Group—57,000+ engineers in 30 countries—we deliver across the entire product development cycle, from consulting to full project outsourcing.

When you join ALTEN Technology USA, you'll collaborate on some of the world's toughest engineering challenges, supported by mentorship, career growth opportunities, and comprehensive benefits. We take pride in fostering a culture where employees feel valued, supported, and inspired to grow.

We are seeking a hands-on and detail-oriented professional with at least 2 years of experience in Commissioning, Qualification, and Validation (CQV) within the pharmaceutical or chemical industry. The ideal candidate will have a solid understanding of GMP and nGMP activities, strong communication skills to coordinate across departments, and the ability to manage qualification projects from planning through execution. This is a fully onsite position based in East Windsor, NJ.

Responsibilities:

• Review basic and detailed designs to ensure compliance with quality and design standards.
• Plan, coordinate, and execute qualification and commissioning activities for new systems and equipment changes.
• Identify and differentiate GMP and non-GMP activities within project scopes.
• Develop, review, and execute qualification protocols (IQ/OQ).
• Oversee supplier services related to calibration and qualification (including FAT/SAT activities).
• Serve as the central point of contact between Production, Engineering, and Quality departments throughout the qualification process.
• Conduct qualification and commissioning of various equipment and systems, including spray dryers, reactors, tanks, pumps, HVAC systems, cleanrooms, sealing machines, scales, utilities, and other pharmaceutical process equipment.
• Evaluate chemical compatibilities of equipment and systems under specific process and cleaning conditions.

Qualifications;

• Minimum of 2 years of experience in CQV activities within the pharmaceutical or chemical industry.
• Proven experience in developing and executing qualification protocols, particularly IQ and OQ.
• Strong understanding of GMP standards and regulatory expectations.
• Experience coordinating with cross-functional teams and external suppliers.
• Excellent organizational, analytical, and communication skills.
• Ability to work fully onsite in East Windsor, NJ.

The actual salary offered is dependent on various factors including, but not limited to, location, the candidate's combination of job-related knowledge, qualifications, skills, education, training, and experience.

ALTEN Technology is an Equal Opportunity Employer. Our Policy is to extend opportunities to qualified applicants and employees on an equal basis regardless of an individual's age, race, color, sex, religion, national origin, disability, sexual orientation, gender identity/expression or veteran status.

Please beware of job seeker scams and see this important notice on our careers page for more information about our recruiting process.

Compliance Notice: Alten USA is a federal contractor subject to the requirements of the Vietnam Era Veterans' Readjustment Assistance Act (VEVRAA) and Executive Order 11246. We are an Equal Opportunity Employer and consider all qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

Drug Screening Requirement: As a federal contractor, Alten USA maintains a drug-free workplace. All candidates selected for employment will be required to successfully complete a pre-employment drug screening as a condition of hire.