Principle Validation Specialist (Biotech)
Today, Lonza is a global leader in life sciences operating across five continents. While we work in science, there's no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that's the kind of work we want to be part of.
Lonza has an exciting opportunity for a Sr. Validation Specialist to join our MODA Team in Wayne, PA. This position is 100% remote, with a preference for candidates based on the East Coast. As a global leader in life sciences, Lonza thrives on innovation and collaboration. In this role, you'll ensure software validation processes meet regulatory standards, driving efficiency and quality in pharmaceutical manufacturing. If you're passionate about validation, compliance, and making an impact, we invite you to explore this opportunity.
Key Responsibilities:
Provide technical leadership and accountability for validation packages for commercial version releases, including design of test method setups (technical design) and test case creation to accomplish test case objectives.
Develop strategy for the validation of software ensuring compliance to regulatory requirements.
Generate internal and external facing base level documents and/or templates such as URS, FRS, VP, TP, SCS, RA, RTM and SOPs in support of validation activities.
Manage the update of client facing documentation for commercial software packages.
Generate and execute computer validation (IQ and OQ) documentation for commercial software releases.
Perform assessment on MODA EM, MODA ES, and WinKQCL to ensure compliance with part 21 CFR Part 11, Annex 11, and GAMP 5.
Lead Collaborate with QA and Product Delivery to ensure successful planning, execution and delivery of validation projects.
Support Regulatory inspections and support both internal and partner audits. Implement corrective actions as needed for audit responses.
Lead and perform evaluations of the impact of software changes to the Validation document package
Key Requirements:
Minimum of 7 years of proven experience in life sciences gained in an academic or industry setting.
Experience in managing multiple validation projects, developing plans, managing to project schedules and directing vendor/contract resources in creating CSV deliverables.
Thorough understanding of the Life Cycle Validation approach and practical working knowledge of computer system validation requirements.
Extensive knowledge of validation of cGMP automation/computerized systems within regulated GXP environments.
Understanding of industry standards and best practices for computer systems validation such as GAMP 5, 21 CFR Part 11 and Part 211, Eudralex Volume 4 and Annex 11, and ICH Q7, Q8, Q9, Q10, and all current regulatory guidance on Data Integrity.
Proven team management with excellent interpersonal and communication skills.
Attention to detail with an ability to perform critical review of various types of technical documents.
Must be self-motivated and comfortable in a fast-paced, demanding and dynamic work environment.
MODA / LIMS / MES experience a plus.
We recognize that attracting, developing and retaining the best talent is key to our strategy and success as a company. As a result, we aim for flexibility in structuring competitive compensation offers to ensure that we are able to attract the best candidates. As required by law in this state, the quoted salary range for this remote position is $100,000.00 – $170,000.00. We use broad salary ranges that reflect the competitive market for similar jobs, provide sufficient opportunity for growth as you gain experience and expand responsibilities; while also allowing for differentiation on performance based on the breadth of our ranges, most new hires will start at the company between the lower and the middle part of the applicable range. We tailor our offers within the range based on job-related factors, including organizational needs, internal equity, market data, geographic area and the selected candidate's experience, education, industry knowledge, location, technical and/or communication skills and other factors that may prove relevant during the selection process. This range is only inclusive of base salary, and base pay is just one component of Lonza's total compensation package for employees. Full-time employees are eligible to receive a performance-related bonus, as well as a comprehensive benefits package including medical and dental coverage, 401k plan, life insurance, short-term and long-term disability insurance, an employee assistance program, paid time off (PTO), and more.
Every day, Lonza's products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.
People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.
Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.
