Job Description

What You’ll Do
The Senior Validation Engineer leads and performs the Bedford site’s validation projects, including start-up, commissioning, qualification, validation, and revalidation activities for facility, equipment, critical utilities, automation/computer systems, cleaning, sterilization, and medical device/drug product manufacturing processes in accordance with current Good Manufacturing Practices (cGMP), ISO requirements, and ICH guidelines. Reporting to the Validation Manager, this role works cross-functionally across the organization to define, execute, and deliver site validation projects.

How You’ll Contribute

• 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.
• Travels to vendor facilities (domestic and international) to perform Factory Acceptance Tests (FAT).
• 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.
• 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.
• Trains and mentors junior engineers and consultants as needed.
• Responsible for other duties and projects as assigned.

What It Takes

The job requires the ability to act on problems of diverse and highly technical scope, requiring critical thinking and interaction with internal and external technical professionals. The position exercises broad judgment in selecting optimum methods, techniques, and evaluation criteria for obtaining results. The role may require coordination of activities of other personnel such as contractors, specialists, and interns to support validation assignments.

What You Bring

• Bachelor’s Degree in Engineering, science, or closely related discipline is desired with 5+ years of significant engineering and/or operational 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 instrument, computer system, and process validations.
• Expertise in FDA, EMA, and ICH qualification/validation requirements and creative risk-based approaches for meeting and exceeding minimum requirements.
• Thorough understanding of key supporting quality systems including change control, deviation/non-conformance, and CAPA, including expertise in root cause analysis.
• Excellent analytical and problem-solving skills coupled with strong presentation skills.
• Excellent written and verbal communication skills.

Nice to Have

• 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 medical device manufacturing.

The salary range provided is based on the Company’s reasonable estimate of the base salary pay range for this position at the time of posting. Actual base pay is determined by several factors relevant to the position, including skills, competencies, experience, education, and geographic location. 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. At Anika, we take pride in offering robust Total Rewards, inclusive of market-leading benefits to meet our employees where they are in their career and in life.

The compensation and benefits information is provided as of the date of this posting. Anika reserves the right to modify compensation and benefits at any time, subject to applicable law.