Verification Engineer & Validation R&D Engineer

Katalyst CRO; Raynham (MA); On-site; USD 80,000 - 110,000; Full time

Job summary

An established industry player in pharmaceutical manufacturing is seeking a Verification Engineer & Validation R&D Engineer to join their dynamic team. This role is pivotal in ensuring compliance with quality standards and regulations while fostering collaboration among multidisciplinary teams. You will be responsible for defining manufacturing processes, leading documentation efforts, and applying your analytical problem-solving skills to address challenges. If you have a strong background in manufacturing technologies and a proactive approach, this opportunity will allow you to make a significant impact in a vital sector.

Qualifications

• 5+ years of experience in manufacturing technologies and validation.
• Knowledge of ISO13485 and FDA 21 CFR Part 820 regulations.

Responsibilities

• Establish equipment requirements and align specifications with quality standards.
• Lead qualification documentation and support teams in issue resolution.

Skills

Analytical Problem-Solving

Organizational Skills

Interpersonal Skills

Manufacturing Technologies

Validation Knowledge

Education

Bachelor's Degree

Master's Degree

Job description

Join to apply for the Verification Engineer & Validation R&D Engineer role at Katalyst CRO.

Responsibilities include establishing equipment requirements, aligning specifications with quality standards, applying analytical problem-solving, defining manufacturing process flow, owning DMR for NPI, leading qualification documentation, and supporting teams in issue resolution. The role involves working closely with multidisciplinary teams and suppliers.

Requirements include a bachelor's degree (master's preferred), 5+ years of experience in manufacturing technologies and validation, knowledge of relevant regulations (ISO13485, FDA 21 CFR Part 820), and familiarity with various manufacturing processes. Strong organizational, interpersonal skills, and a proactive, creative approach are essential.

Additional Details

• Seniority Level: Mid-Senior level
• Employment Type: Contract
• Industry: Pharmaceutical Manufacturing