PDCP - Validation Assistant Manager

About SHL Medical

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

As a Validation Assistant Manager at SHL, you will play a pivotal role in ensuring the integrity and efficiency of our manufacturing processes. You will be responsible for defining and executing SHL’s validation strategy to qualify novel production equipment and manufacturing processes for metal, packaging, and printing components. Your expertise will drive validation activities including equipment validation (EV) and process validation (PV), across the entire validation lifecycle from Plan to Retire.

• In this role, you will lead a team of 6-8 highly talented and experienced validation engineers, overseeing validation activities locally and overseas, incl. resource planning and roadmap construction. As part of the department management team, your administrative responsibilities include coordination and tracking of validation activities, and ensuring the team meets its goals in accordance with the company strategy.
• A successful candidate will demonstrate outstanding leadership capabilities and a strong ability to improve and enhance existing processes, contributing to the continuous improvement and strategy key objectives of the company, even when facing ambiguity.

Main Responsibilities

• Lead the validation team both operationally and at a personnel level.
• Monitor all validation activities, including resource estimations and roadmap construction.
• Develop effective validation strategies for internal manufacturing processes involving Metal/Packaging/Printing components and their respective production equipment.
• Participate in the design, development, commissioning, and qualification of manufacturing equipment and component processes, contributing effectively as a member of a diverse, cross-functional engineering team.
• Provide technical assessments and validation reviews/approvals for engineering, process, and standard operating procedure changes.
• Supervise failure investigations and root cause analyses.
• Engage in internal and external audit activities.
• Review, optimize, and approve validation documents and protocols (IQ, OQ, PQ, PV).

Minimum Qualifications

• Bachelor or Master degree in Mechanical Engineering, Material Science, Biomedical Engineering, or related field.
• 5+ years of engineering and validation experience in the medical device, pharmaceutical, technology, or related industries.
• Demonstrated experience in management and people leadership.
• Proficiency in experimental design, problem-solving, and data analysis.
• Strong communication and project management skills, along with logical and critical thinking.
• Fundamental knowledge with quality related statistical concepts (e.g., Six Sigma, Cpk, Ppk evalations, etc.).
• Knowledge of GMP, ISO, and FDA regulatory requirements (e.g., ISO 13485, 21 CFR Part 11, 21 CFR 820, and FDA GMPs).

Preferred Qualifications

• Experience of developing manufacturing equipment or metal/printing/packaging component forming process.
• Experience of digitalize daily practice by using Excel, Power Apps or other programing language.

Language skills

• Fluent in Mandarin
• Good at English verbal communication, writing and reading (TOEIC 785 or above)

We Offer :

• Challenging assignments in a fast-growing and innovative industry.
• A multicultural team and modern working environment with state-of-the-art facilities and technologies.
• A place where we take pride in the inclusive and collaborative environment we have built - one where a true sense of belonging fosters meaningful exchange and shared growth.
• Various opportunities for personal and professional development within a global organization.

Interested in joining SHL Medical and in supporting us with your expertise and personality? Then we look forward to receiving your application to our Talent Acquisition Department.

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

Please note: We do not accept applications from recruitment agencies for this position.