Validation Engineer

Responsibilities

• Leading and executing validation activities associated with the installation, qualification, and lifecycle management of a new automated shot peening system.
• Development and approval of a comprehensive Validation Master Plan (VMP).
• Generation and execution of Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols.
• Applying a risk-based validation approach in accordance with ISO 14971 principles.
• Oversight of requalification and validation activities required for the restart of a fully automated rod cell.
• Coordination of facility and equipment modifications necessary to support the new installation.
• Ensuring compliance with change control and validation procedures during the transition into a scale-up phase.
• Developing, coordinating, and conducting technical reliability studies and evaluations.
• Completing risk analysis studies of new design and processes.
• Ensuring corrective measures meet acceptable reliability standards.
• Developing mathematical models to identify units, batches or processes posing excessive failure risks.
• Proposing changes in design or formulation to improve system and/or process reliability.
• Determining units and/or batches requiring environmental testing and specifying minimum number of samples to obtain statistically valid data.

Requirements

Candidates must be legally authorized to work in the United States and must be able to sit on Primary Talent Partners W2 without sponsorship.

Qualifications

• 1-3 years of Medical Device industry experience.
• Familiarity with FDA 21 CFR Part 820, EU 217/745 (EU MDR).
• Knowledge of ISO 13485, ISO 14971, IEC 60601.
• Experience in validation of automated cells, Installation, Operational and Performance Qualifications.
• Shot peen experience - Certified in shot peening (level 1 or level 2).
• Strong written and verbal communication skills and ability to work cooperatively as part of a cross-functional team.
• 4+ years of engineering experience in a medical device manufacturing environment.
• Collaboration with a wide range of stakeholders and internal customers, from manufacturing process to quality and automation engineers.

Skills

• Ability to write validation master plans.
• Understanding of software validation.
• Understanding of automation and its validation.

Pay

$40 - $45.00/hr; W2 contract, no PTO, no Benefits. ACA-compliant supplemental package available for enrollment.

Schedule

8-month contract with a potential for extension.

Benefits

N/A

Pay

$40 - $45.00/hr; W2 contract, no PTO, no Benefits. ACA-compliant supplemental package available for enrollment.

Schedule

8-month contract with a potential for extension.

Benefits

N/A

Company Information

Primary Talent Partners is an Equal Opportunity / Affirmative Action employer committed to diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, age, national origin, disability, protected veteran status, gender identity, or any other factor protected by applicable federal, state, or local laws.