Senior Quality Engineer Validation and Risk

Senior Quality Engineer – Risk and Validation

Location: Charleston, South Carolina, US

SHL Medical is a world-leading provider in the design, development, and manufacturing of advanced self-injection devices. With a global team of 6,000 employees, we partner with leading pharmaceutical and biotech companies to deliver innovative autoinjectors, pen injectors, and other drug delivery systems that ensure effective treatment for patients. Headquartered in Switzerland since 2018, with key operations in Sweden, Taiwan, and the US, we are united by a commitment to innovation, impact, and growth. Together, we empower our people to develop solutions that make a meaningful difference in the lives of millions of patients while fostering a supportive, inclusive, and dynamic workplace for our colleagues.

Job Overview

Senior level Validation personnel who applies regulatory, compliance and engineering knowledge to set requirements related to end to end process validation. The candidate ensures risk-based validation approach is implemented while maintaining compliance to external regulations including, but not limited to FDA Quality System Regulation (21 CFR Part 820), ISO 13485, ISO 11608 & ISO 14971.

Main Responsibilities

• Lead risk evaluation of existing validation strategies against mass production NCMRs, CAPAs, and Change Controls.
• Establish new validation strategies based on above risk evaluation to ensure validated process deliver products that meet customer requirements consistently.
• Derive implementation strategies of above mentioned changes on validation strategies.
• Work with QE program managers and cross functional team include but not limited to Tech Transfer team, manufacturing engineering team on prioritizing the implementation strategies to ensure timely, risk-based, and effective implementation.
• Participate in tech transfer projects to ensure accurate risk identification and mitigations are in place of each tech transfer.
• Review and approve the Master Validation Plan and Validation Plans of respective projects, ensuring the criteria are aligned to NCHS site, customer, regulatory, quality and risk requirements. 
• Manage a team of risk and validation engineers.
• Hiring, develop and retain risk and validation engineers.
• Collaborate with Risk Management and Quality personnel to ensure all critical to quality attributes are validated to the right level and sustenance plans are set in place for mass manufacturing.
• Drive CAPA related to general SHL validation process and participate in product related CAPA when necessary.
• Ensure all validation records are maintained and periodic verification executed by process owners according to compliance requirements.
• Material Review Board
• Change Control approval
• Change Request & review board
• Conduct internal audits
• Support test development activities
• Performs other related duties as assigned.

Skills and Qualification

• Validation experience in medical device, pharmaceutical or biotechnology industry.
• End to End [point of use] validation mindset and skills
• Extensive tech transfer process validation is required
• Demonstrate use of Risk-based approach. Good knowledge of FDA, GxP, ISO 13485, and ISO 14971.
• Demonstrated and applied a broad knowledge of field of specialization through successful completion of moderately complex assignments.
• Good communication and interpersonal skills and demonstrate ability to participate in inter-departmental discussion and resolve challenges a timely manner.

We Offer

• Competitive compensation package
• Modern working environment with state-of-the-art facilities and technologies
• Challenging assignments in a fast growing and innovative industry
• Position in a dynamic, international team of highly skilled professionals
• Various opportunities for personal and professional development within a global organization

Please note that SHL is a drug free employer. This offer of employment is contingent upon your successful completion of various preemployment screenings, including, but not limited to, a drug test, employment verification, reference checks, and a criminal background check.

For more information on SHL Medical, please visit: shl-medical.com