Founded in 1927 and headquartered in Warsaw, Indiana, USA, Zimmer Biomet is a global leader in musculoskeletal healthcare. We design, manufacture and market orthopaedic reconstructive products; sports medicine, biologics, extremities and trauma products; spine, bone healing, craniomaxillofacial and thoracic products; dental implants; and related surgical products.
We collaborate with healthcare professionals around the globe to advance the pace of innovation. Our products and solutions help treat patients suffering from disorders of, or injuries to, bones, joints or supporting soft tissues. Together with healthcare professionals, we help millions of people live better lives.
For the European Headquarters, based in Winterthur (Switzerland), we are looking for a
Senior System Validation Engineer
Your main responsibilities:
Leading, reviewing, executing and contributing to computer system validation and qualification activities at plants in Europe as well as participate in audits of suppliers of automated and IT systems.
Acting as a cross-functional, inter-business unit resource and ensure compliance with regulatory and corporate policies and standards.
Developing, reviews and approves computer system validation plans, requirement specifications, qualification protocols (FAT, SAT, DQ; IQ, OQ, PQ) and final reports for automated and IT systems as well as performing gap and risk analysis.
Analyzing, improving and writing standard operating procedures related to computer system validation activities and projects.
Maintaining current knowledge of US and International regulatory requirements and guidelines, 21CFR Part 820, 11, GAMP, cGMP, MDD.
Providing assurance that automated and IT systems remain in a validated state throughout their life cycle as well as reviewing and approving respective change control documents.
Support all departments during inspections and audits through the authorities and train other personnel to assist in the execution of computer system validation activities.
Partnering with Operations, Engineering, R&D, IT, Clinical, Quality and others as well as liaises with corporate headquarter validation staff.
Your Qualifications and Experience:
Bachelor degree in computer science, automation, engineering or equivalent work experience.
At least 3 years computer system or software validation experience in medical devices or pharmaceutical related industry.
Experience in software development, software- or system-engineering.
Strong oral and written communications abilities in English and German, ability to speak and write additional language would be an asset.
Excellent problem-solving ability and analytical skills, strong sense of initiative, follow-through and attention detail as well as excellent interpersonal skills.
Ability to apply and to interpret regulatory requirement (ISO/CFR/IEEE) with regards to computer systems and auditing to these standards as an SME.
Familiar with a variety of office software packages including MS Word, Excel, PowerPoint, Visio and a documents management system.
Ability to implement the V-model (GAMP), to execute GxP assessments and risk analysis for computer systems as well as the ability to moderate workshops.
This dynamic Job position includes travel activities up to 10%.
If you seize this opportunity, you will able to develop your international experience and be a part of a great and truly global team. Zimmer Biomet offers a wide range of challenging career advancement opportunities and a dynamic work environment. We look forward to receiving your complete application.
Jan Lucarelli Recruiting Coordinator Tel: +41 52 233 53 58