Validation Specialist

Job Title: Validation Specialist

Job Description

We are seeking a dedicated Validation Specialist to manage validation programs for drug products, drug substances, and starting materials. You will play a crucial role in supporting validation documents to aid process characterization across drug substances and products, as well as implementing validation policies.

Responsibilities

• Handle validation programs for drug products, drug substances, and starting materials.
• Support the creation and maintenance of validation documents to aid process characterization.
• Implement validation policies and procedures.
• Support the technical operations group to ensure compliance with process validation protocols and address process deviations.
• Assist with tech transfer and validation activities.
• Resolve quality issues and perform Corrective and Preventive Actions (CAPA), investigations, root cause analysis, and risk assessments.

Essential Skills

• Proficiency in validation, drug substance, and process validation.
• Experience with CAPA and investigation processes.
• Knowledge of drug product and process characterization.
• Familiarity with tech transfer, MSAT, and process deviation.
• Understanding of GMP, audit processes, and process development.

Additional Skills & Qualifications

• Bachelor's degree with 5 years of industry experience, Master's degree with 3 years, or PhD with 2 years.
• Experience working in a Contract Development and Manufacturing Organization (CDMO).
• Experience in biologics, drug product, and drug substance.
• Ability to support and mentor junior team members.

Work Environment

The position is 100% onsite, Monday through Friday, from 9:00 am to 5:00 pm, based in Fargo, ND. The work environment is business casual. Employees have opportunities for growth within the company, including the ability to move between operating companies internally. Starting in 2026, the company will offer permissible time off instead of accrued time off.

This is a Permanent position based out of Waltham, MA.

The pay range for this position is $100000.00 - $130000.00/yr.

They have health, dental, vision, and 401k. They also will get permissive time off, so there is no specific accrual process in 2026.

This is a fully onsite position in Waltham,MA.

This position is anticipated to close on Mar 26, 2026.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I is embedded into our culture through:

• Hiring diverse talent
• Maintaining an inclusive environment through persistent self-reflection
• Building a culture of care, engagement, and recognition with clear outcomes
• Ensuring growth opportunities for our people

Actalent is an equal opportunity employer.

About Actalent

Actalent is a global leader in engineering and sciences services. For more than 40 years, we’ve helped visionary companies advance their goals. Headquartered in the United States, our teams span 150 offices across North America, EMEA, and APAC—with four delivery centers in India led by 1,000 extraordinary employees who connect their passion with purpose every day.

Our Bangalore, Hyderabad, Pune, and Chennai delivery centers are hubs of engineering expertise, with core capabilities in mechanical and electrical engineering, systems and software, and manufacturing engineering. Our teams deliver work across multiple industries including transportation, consumer and industrial products, and life sciences. We serve more than 4,500 clients, including many Fortune 500 brands. Learn more about how we can work together at actalentservices.com.

Salary : $100,000 - $130,000