CQV Engineer - Pharmaceutical Manufacturing (Hybrid Opportunity)

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Written by AI from the job title and company, not by CONFLUX SYSTEMS, so some details may not match this job. The employer's own page has the real description.

Job Overview

The CQV Engineer - Pharmaceutical Manufacturing at Conflux Systems will be responsible for ensuring that all manufacturing processes and equipment meet the required regulatory standards and specifications. This hybrid position entails conducting commissioning, qualification, and validation of manufacturing systems, collaborating with cross-functional teams, and ensuring compliance with industry regulations to guarantee product quality and safety. The ideal candidate will possess strong technical knowledge and problem-solving skills, fostering an environment of continuous improvement in operational efficiencies and compliance standards.

Job Responsibilities

• Develop and execute validation protocols for manufacturing processes and equipment.
• Conduct risk assessments and develop risk mitigation strategies.
• Collaborate with engineering and production teams to ensure that all systems are functioning efficiently and effectively.
• Prepare and review documentation and reports related to commissioning and qualification activities.
• Coordinate and lead validation activities during equipment installation and start-up.
• Provide training and guidance to team members on compliance and validation standards.
• Support internal and external audits to verify system compliance within the manufacturing environment.

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, or a related field.
• A minimum of 3 years of experience in Commissioning, Qualification, and Validation within a pharmaceutical manufacturing environment.
• Strong understanding of FDA regulations, cGMP standards, and validation requirements.
• Excellent problem-solving and analytical skills.
• Proficient in Microsoft Office Suite; familiarity with validation management software is a plus.
• Strong communication skills, both written and verbal.

Technologies & Tools

The position utilizes a variety of technologies and tools essential for qualification and validation processes in the pharmaceutical industry. These include validation management software, document management tools, and project management systems. Familiarity with statistical analysis software and data analytics tools is also beneficial for ensuring comprehensive validation and compliance assessments.

Ideal Candidates

The ideal candidates for the CQV Engineer position will possess a strong technical background and demonstrate an unwavering commitment to regulatory compliance and quality assurance. They should be proactive self-starters with the ability to work independently, as well as engage collaboratively with multi-disciplinary teams. Strong attention to detail, excellent organizational skills, and an eagerness for continuous improvement will contribute significantly to the success of candidates in this dynamic environment.