Senior Validation Engineer

Anika Therapeutics • Bedford, MA

1d

About The Position

This position is responsible for leading and performing the Bedford Site’s Validation projects that includes start-up, commissioning, qualification, validation and revalidation for facility, equipment, critical utility, automation/computer system, cleaning, sterilization, and medical device/drug product manufacturing processes according to current Good Manufacturing Practices (cGMP), ISO requirements, and ICH guidelines. Reporting to the Validation Manager, this position works internally across the Anika organization to define, execute and deliver the site’s validation projects.

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.
• 5+ years of validation experience in pharmaceutical, medical device or FDA regulated environments.
• Strong understanding of cGMP and regulations related to facility, utility, equipment, analytical instruments, computer systems and process validations.
• Expertise in FDA, EMA, and ICH qualification / validation requirements and creative risk-based approaches for meeting and exceeding the minimum requirements
• Thorough understanding of key supporting quality systems including change control, deviation / non-conformance, and CAPA. Expertise in root cause analysis
• Excellent analytical and problem-solving skills coupled with strong presentation skills.
• Excellent written and verbal communications skills.

Nice To Haves

• Advanced degree or post-graduate coursework desirable
• Strong experience in Analytical Instrument Qualification (AIQ), Computer System Validation (CSV) and Computer Software Assurance (CSA).
• Working knowledge using Kaye Validator or equivalent thermal mapping systems
• Direct experience in commissioning and qualification of critical utility systems, critical process equipment and computer systems
• Direct experience working in an aseptic formulation and fill manufacturing environment
• Strong knowledge of industry standards for sterility assurance in an aseptic manufacturing environment
• Solid understanding of quality risk management (QRM) principles and statistical concepts
• Subject matter expert on regulations and best practices pertaining to validation including ISO 13485, GHTF Process Validation Guidance and other applicable standards used in the medical device manufacturing.

Responsibilities

• Leads the delivery of validation within complex, capital projects overseeing engineering, quality, and compliance aspects of validation.
• Authors, executes, and summarizes commissioning, qualification and validation protocols.
• Travel to vendor facilities (domestic and international) to perform Factory Acceptance Tests (FAT).
• Conducts Risk / Impact assessments and establish system boundaries.
• Ensures protocols, records, and procedures are in compliance with current Good Manufacturing Practices (cGMP), industry standards and approved SOPs.
• 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.
• Train and mentor junior engineers and consultants as needed.
• 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: Senior