Senior Validation Engineer II – QC Instrument Lead (Hybrid)

BioSpace; Lexington (MA); Hybrid; USD 97,000 - 152,000; Full time

Benefits offered by this job

Comprehensive Healthcare

401(k) with company match

Generous vacation time

Tuition reimbursement

Health & Wellness programs

Community Outreach Programs

Professional training opportunities

Job summary

An established industry player is seeking a Senior Validation Engineer to enhance quality control operations in a hybrid role. This position involves executing analytical instrument lifecycle activities, managing qualification projects, and ensuring compliance with regulatory standards. You will collaborate with cross-functional teams to optimize project plans and implement continuous improvements. The role offers an opportunity to lead and train junior staff while contributing to the future of quality control in biopharmaceuticals. Join a company dedicated to transforming patient care through innovative solutions and best-in-class support programs.

Qualifications

• 7+ years experience in biopharmaceutical manufacturing validation.
• Knowledge of computer systems and software validation ideal.

Responsibilities

• Execute analytical instrument lifecycle activities and manage projects.
• Coordinate with vendors and ensure compliance with regulations.

Skills

Analytical Skills

Project Management

Communication Skills

Problem-Solving

Investigation Techniques

Education

Bachelor's Degree in Engineering or Science

Advanced Degree (ideal)

Tools

TrackWise

Veeva

Job description

An established industry player is seeking a Senior Validation Engineer to enhance quality control operations in a hybrid role. This position involves executing analytical instrument lifecycle activities, managing qualification projects, and ensuring compliance with regulatory standards. You will collaborate with cross-functional teams to optimize project plans and implement continuous improvements. The role offers an opportunity to lead and train junior staff while contributing to the future of quality control in biopharmaceuticals. Join a company dedicated to transforming patient care through innovative solutions and best-in-class support programs.