Senior Process & Validation Engineer

Senior Process & Validation Engineer

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

This role is embedded in the Manufacturing Engineering group within our Global Operations Engineering team at our new state-of-the-art device manufacturing facility in North Charleston, South Carolina.  This role serves at the intersection between process engineering and validation with the candidate expected to understand and support onsite validation activities, as well as serving as a process SME, driving improvements and supporting investigations and troubleshooting.

Main Responsibilities

• Serve as a process SME, leading and supporting process introduction, development, troubleshooting, and improvement initiatives at the site
• Lead and support acceptance and CQV activities (commissioning, qualification, and validation) for production equipment and processes, including developing/authoring compliant validation plans and protocols, as well as supporting the associated change control processes
• Collaborate internally and across departments to drive improvements to SHL’s production equipment and associated processes
• Work with the broader validation team, including global colleagues, to drive efficiency, simplicity, and robustness in validation process updates
• Provide input and make updates to validation-related SOPs, work instructions, and guidelines to improve the overall validation lifecycle
• Work with fellow engineers to drive and support root cause analysis, NCMR investigation, and CAPA planning
• Provide support for internal and external audits and investigations both through validation documentation ownership, as well as technical SME input
• Remaining up-to-date and ensuring compliance with current industry trends as well as Quality Systems, ISO13485, cGMP and other relevant regulatory protocols
• Performs other related duties as assigned.

Skills and Qualification

• Bachelor’s degree in Engineering or equivalent education/experience required
• A minimum of 4 years of relevant experience as a Validation Engineer and/or Process Engineer, preferably in in the medical device industry
• Demonstrated knowledge of regulations and standards that apply to the medical device industry (cGMP, ISO13485, CFR 820, etc.)
• Understanding of the application of quality systems to the medical device industry
• Statistical analysis knowledge, including an understanding of how to execute and interpret Design of Experiments (DOE).
• Knowledge of common problem-solving and Root Cause Analysis (RCA) methodologies. Six Sigma certification is a plus

Preferred:

• Ability to perform multiple tasks and prioritize workload.
• Effective analytical, technical, and problem-solving skills.
• Excellent intercultural and interdisciplinary communication skills
• Ability to work independently with strong attention to detail and focus on efficiency, effectiveness and cost
• Passionate & committed self-starter with “can do” attitude, team player and taking responsibility to get the job done

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