Mantell Associates is currently partnered with a fully integrated CDMO with global sites, who are seeking a Senior Quality Engineer to provide experienced QA support from product development through cGMP clinical and commercial production.

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Senior Quality Engineer - Responsibilities:

• Oversees F&E activities in real time (QAOTF) to ensure compliance with internal procedures and global regulatory requirements are met

• Provide equipment, system, and facility validation /qualification guidance and ongoing support for established / validated processes

• Leading cross-functional activities, in providing approach, methodology and deliverables

• Partnering with project teams to provide solutions for validation of systems following a risk-based approach

• Assist in developing and reviewing validation documents with functional teams, ensuring the documentation meets compliance requirements, quality standards, and current industry expectations

• Track and report status and progress of qualification activities or projects to direct manager and / or management review

• Identifies root causes of problems in the production process or as a result of investigations; recommends and/or implements corrective measures

• QA review and approver or risk assessments

• Quality point of contact for shutdown activities

• Provide Quality oversight in change control activities to ensure technical and document impact assessments are performed in a compliant manner and the regulated systems are maintained in a validated state

• Perform investigations and implement corrective actions related to CAPAs and deviations

• Representing Quality Engineering in an emerging industry

• Regular and reliable attendance on a full time basis [or in accordance with posted schedule

• Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company's policies and practices

• Embodies cultural values and aligns daily actions with department goals and company culture

Senior Quality Engineer - Requirements:

• Bachelor's degree required (ChE, EE, IE, ME, CS, or similar) and 5+ years applicable cGMP experience in regulated industry

• Exceptions may be granted for equivalent work experience or graduate degree

• Working knowledge of cGMP regulations 21CFR Part 11, 210, 211, 600 & EU guidelines and good documentation practices and data integrity

• Knowledge of Fill Finish and Biologics production environments preferred

• Familiarity working with electronic batch records

• Detail oriented and strong interpersonal and verbal communication skills

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Mantell Associates is a specialist Pharmaceutical and Life Science headhunting firm. For more information on this opportunity, contact us at +1 (786) 485 1298.