Validation Scientist

Job Title: Validation Scientist

Job Description

We are seeking a dedicated Validation Scientist to manage and support validation programs for drug products, drug substances, and starting materials. The role involves supporting validation documents to aid process characterization across drug substance and drug product, implementing validation policies, and assisting with tech transfer and validation activities.

Responsibilities

• Handle validation programs for drug products, drug substances, and starting materials.
• Support validation documents for process characterization across drug substance and drug product.
• Implement validation policies.
• Support tech operations group to ensure process validation protocols and address process deviations.
• Assist with tech transfer and validation activities.
• Resolve quality issues and CAPA by performing investigations, root cause analysis, and risk assessments.

Essential Skills

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

Additional Skills & Qualifications

• BS with 5+ years of industry experience, MS with 3+ years, or PhD with 2+ years of experience.
• Experience working in a CDMO.
• Experience on an MSAT and Tech Operations team.
• Experience in biologics, drug product, and drug substance.
• Ability to support and mentor junior team members.

Work Environment

This position is 100% onsite from Monday to Friday, 9:00 am to 5:00 pm. The work environment is business casual. The role offers opportunities for professional growth, including mentoring junior scientists and potential moves within operating companies that count as internal movements. 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 16, 2026.

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.