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.
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.
The job requires the ability to work on diverse complex issues where analysis of situations or data requires an in-depth evaluation of a variety of factors. The position exercises broad judgment in selecting optimum methods, techniques, and evaluation criteria for obtaining results.
Bachelor's Degree in Engineering, science, or closely related discipline is desired with 5+ years of significant engineering and/or operational experience.
35 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.
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.
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.
Validation Engineer II • Bedford, MA, US
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