Job Description

Date: Jan 23, 2025 Location: San Diego Company: Wacker BioTech US Inc. Do you want to take responsibility and make a difference with your work? With your expertise, we can achieve great goals together. We are WACKER - Reliable. Determined. Ambitious. As one of the world's most research-intensive chemical companies, we've been making countless products that are an integral part of your everyday life possible for over 100 years. From vegan food to resource-efficient buildings to solar cells, we develop sustainable solutions that change the future. To strengthen our team in San Diego , we are looking for you as a(n) Computer System Validation Specialist III . This is Us: You know us. You just didn't know it. WACKER is a global chemical manufacturer that prides itself on "Creating Tomorrow's Solutions". WACKER materials are so versatile and adaptable, they have virtually unlimited applications just about anywhere imaginable, making WACKER an integral part of daily life. Whether it's protecting buildings from the elements, a tube of toothpaste, a cell phone, airbags, or cosmetics, people from all over the world come into contact each day with our products and achievements. We are looking for capable, innovative, and enthusiastic achievers to join our team and grow with us. We are currently seeking Computer System Validation (CSV) Specialist at the site in San Diego, CA. What you will do: The Computer System Validation (CSV) Specialist is an essential position in the CSV team. The CSV Specialist is responsible for developing validation deliverables for GxP computer system used in Lab, Manufacturing and Enterprise System in Wacker San Diego Site. The position will entail building strong cross-functional relationships throughout the organization and translating requirements into CSV project. The role will also require supporting internal/external audits and other computer system lifecycle activities as required for the CSV program. The CSV Specialist will be responsible to develop and execute validation deliverables and Computer System Lifecycle activities including but not limited to Deviation, CAPA, Change Control, and Periodic Review. This role will also support global computer system validation project from the Global Bio-digital Solution team, as well as support Veeva QMS/EDMS/Training Vaults administration as required, Develop and execute computer system validation deliverables including but not limited to URS, FRS, Risk Assessment, Design Specification, IQ/OQ/PQ, RTM and Validation Summary Report. Support global computer system implementation and validation. Lead computer system validation activities in WBU site. Ensure computer systems in WBU site are compliance with CSV SOPs. Provide CSV support in deviation, CAPA, Change Control, and computer system vendor evaluation. Perform periodic review for computer system used in WBU site. Support regulatory filings and inspection as CSV SME. Support CSV remediation activities from external and internal audit. What we need from you: Bachelor's degree in science with 6+ years or MS/PhD with 4+ years of GMP/Relevant Industry Experience. (Chemistry, biochemistry, or related discipline preferred). Must have 4+ years of experience in pharmaceutical (FDA regulated industry) computer system validation. Ability to travel less than 10%. GMP, GAMP, Annex 11, 21CFR knowledge and experience Statistical analysis Excellent analytical interpretation skills Risk-based application of validation principles Committed to delivering high quality results, overcoming challenges, focusing on what matters Implementing change initiatives and leading change. Ability to lead and implement CSV project with minimum supervision. Strong problem solving and decision-making skills Good organizational skills and attention to detail. Requires good written, verbal, and interpersonal communication skills and the ability to effectively interact with all levels. Ability to handle multiple assignments and changing priorities. Positive, proactive approach to drive assignments/tasks to completion. Proficiency with Microsoft Word, Excel, PowerPoint Ability or capable of lifting up to fifty (50) lbs. Experience of Veeva Quality Management System and EDMS is a plus. Must have strong hands-on, end-to-end validation experience and application of project controls / management - including familiarity with all project lifecycle phases from requirements gathering through delivery, issues / risk management, change management, release management and retirement management. Experience with wide range of CSV experience including Manufacturing, Lab and Enterprise CSV experience. The anticipated salary range for candidates who will work in San Diego is $82,000 - 106,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc . Wacker is a multi-state employer, and this salary range may not reflect positions that work in other states. What do we offer? WACKER is an equal opportunity employer committed to diversity, equity, inclusion, and sustainability. We are innovators, researchers, and pioneers and we believe that our individual differences are our collective strength. We foster an inclusive environment that promotes individuality, celebrates diversity, and builds cohesive teams. Together, we create exceptional value for our employees, our customers, and our communities by creating a culture of inclusion and equity that enables, empowers, and values our diverse contributions. WACKER strives to reward its employees in a fair and equitable manner. Our Total Rewards Package considers employee wellbeing and is comprised of compensation, benefits, work-life balance, performance & recognition, and career development. Compensation and Incentive plans Medical, Dental, and Vision Insurance effective day 1 Paid Time Off in addition to personal days and holidays Paid parental leave Wellbeing fund Flexible hybrid work arrangements 401(k) with company match Education Assistance Program Career development and advancement opportunities Support for Community Involvement We are looking forward to your online application at Reference Code:28659

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The information contained herein is not intended to be an all-inclusive list of the duties and responsibilities of the job, nor are they intended to be an all-inclusive list of the skills and abilities required to do the job. A minimum requirement for this US-based position is the ability to work legally in the United States on a permanent unrestricted basis. Visa sponsorship is not available for this position, including for any type of US permanent residency (e.g., for a green card). WACKER is proud to be an Equal Opportunity/Affirmative Action Employer, making decisions without regard to race, color, religion, creed, sex, sexual orientation, gender identity, marital status, national origin, age, veteran status, disability, or any other protected class. Nearest Major Market: San Diego Wacker Chemical

Job Tags

Holiday work, Permanent employment, Flexible hours,

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