Validation Engineer

Job Title: Validation Engineer

Job Description:

This role supports buffer and media preparation activities in accordance with batch records and standard operating procedures (SOPs). The position involves routine operations in GMP labs and ISO-classified cleanrooms, as well as maintaining compliance with industry regulations.

Responsibilities:

• Perform buffer and media preparation tasks per batch records and SOPs.
• Conduct routine operations in GMP labs and ISO-classified cleanrooms.
• Support cleaning, inventory control, and material movement in a regulated environment.
• Collaborate with Quality Assurance (QA), Manufacturing, and Facilities teams to maintain operational readiness.
• Maintain clear, detailed, and GDP-compliant records when executing logs, records, and reports.

Requirements:

• 1-3 years of relevant experience.
• Hands-on experience in GMP manufacturing environments with a strong foundation in aseptic operations.
• Experience in pharmaceutical cGxP settings, including GDP, GMP, cleanrooms, gowning, aseptic techniques, and buffer preparation.
• Familiarity with environmental monitoring of classified spaces.
• Strong attention to detail and organizational skills.
• Ability to work effectively in a team environment.
• Bachelor's Degree or equivalent required.
• Proficiency in PC and Microsoft Office tools (Word, Excel, PowerPoint).
• Strong interpersonal and communication skills.
• Ability to adapt to high levels of challenge and change.

This is a 100% onsite role in Cambridge, MA.