Validation Engineer II

About the Role

The Validation Engineer II performs start-up, commissioning, qualification, validation, and revalidation activities for facility, equipment, critical utilities, automation/computer systems, cleaning, sterilization, medical device, and drug product manufacturing processes. This role develops into a subject matter expert in process validation and cleaning/sterilization validation.

Responsibilities

• Authors, executes, and summarizes qualification and validation protocols.
• Conducts Risk / Impact Assessments and establishes system boundaries.
• Ensures protocols, records, and procedures are in compliance with current Good Manufacturing Practices (cGMP), industry standards, and approved SOPs.
• Provides technical input in determining strategy for validation activities.
• Represents validation during site GMP activities and participates on cross-functional teams.
• Coordinates the investigation and impact assessment for all deviated equipment or processes discovered upon calibration or validation.
• Initiates, or provides validation input on quality systems such as CAPAs and change controls.
• Responsible for other duties and projects as assigned.

Requirements

• Bachelor’s Degree in Engineering, science, or closely related discipline is desired with 5+ years of significant engineering and/or operational experience.
• 3–5 years of validation experience in pharmaceutical, medical device, or FDA-regulated environments.
• Strong understanding of cGMP and regulations related to facility, utility, equipment, and process validations.
• Ability to initiate, manage, and close quality systems such as change control, CAPA, and deviation management.
• Detailed experience performing root cause analysis investigations for deviations and non-conformances having technical scope.
• Excellent written and verbal communication skills.

Qualifications

• Advanced degree or post-graduate coursework may be desirable.
• Hands-on experience in process validation of medical device and/or drug product manufacturing processes.
• Knowledge of the fundamentals of Steam Sterilization and Cleaning Validation.
• Solid understanding of quality risk management principles and statistical concepts as applicable to area of responsibility.
• Subject matter expert on regulations and best practices pertaining to validation.
• Practical application and knowledge of ISO 13485, GHTF Process Validation Guidance, and other applicable standards used in medical device manufacturing.

Pay

The salary range for this position is $84,000 – $105,000. Actual base pay is determined by several factors relevant to the position, including skills, competencies, experience, education, and geographic location.

Benefits

• Discretionary bonus program for all full-time employees.
• Comprehensive healthcare benefits.
• Health savings account.
• 401(k) plan with up to 5% company match, including immediate vesting.
• Employee stock purchase plan at a 15% discount.
• Accrued paid time off.
• Additional long-term incentives including stock awards.

Location: Bedford, MA
Employment Type: Full-Time