Validation Engineer II

Anika Therapeutics • Bedford, MA

2d

About The Position

Perform start-up, commissioning, qualification, validation and revalidation for facility, equipment, critical utility, automation/computer system, cleaning, sterilization, medical device, and drug product manufacturing processes.

Strategic Focus Area:

Develops into a subject matter expert in process validation and cleaning/sterilization validation.

Requirements

• Bachelor’s Degree in Engineering, science, or closely related discipline is desired with 5+ years of significant engineering and or operational experience.Bachelor’s Degree in Engineering, science, or closely related discipline is desired with 5+ years of significant engineering and or operational experience.Bachelor’s Degree in Engineering, science, or closely related discipline is desired with 5+ years of significant engineering and or operational experience.Bachelor’s Degree in Engineering, science, or closely related discipline is desired with 5+ years of significant engineering and or operational experience.BS degree in engineering or scientific discipline or equivalent 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 communications skills.

Nice To Haves

• Advanced degree or post-graduate coursework may be desirable.
• Hands on experience on 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 the medical device manufacturing.

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.

Benefits

• Anika also offers a discretionary bonus program for all full-time employees, comprehensive healthcare benefits, health savings account, 401(k) plan with up to 5% company match which includes immediate vesting, employee stock purchase plan at a 15% discount, accrued paid time off, additional long-term incentives including stock awards, and much more.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level