Senior Validation Engineer at PSC Biotech

PSC Biotech provides the life sciences with essential services to ensure that health care products are developed manufactured and distributed to the highest standards in compliance with all applicable regulatory requirements. Our goal is to skyrocket our clients success and you can be a part of our teams achievements. Employing a global team of skilled professionals and experts that span across strategically located offices in North America Europe Asia and the Middle East we are proud of the roles we have fulfilled to help our clients achieve success. The Experience With operations spanning the globe and featuring a multi-cultural team PSC Biotech is passionate about bringing the best and brightest together in an effort to form something truly special. When you make the decision to join our team you will be offered the ability to feel inspired in your career explore your professional passions and work alongside a group of people who will value and nurture your talents. We are firm believers in coaching and developing the next generation of industry leaders and influencers. As such you will not only be offered compensation and benefits structure that rewards you but also be provided with the tools that will help you grow and learn. At PSC Biotech its about more than just a jobits about your career and your future. Your Role We are hiring an experienced Senior Validation this role you will be responsible for drafting executing and reviewing validation protocols with adherence to quality and compliance standards. A strong candidate will demonstrate exceptional attention to detail rigorous documentation practices and effective collaboration across cross-functional teamsExecute validation protocols for equipment systems and processes in compliance with regulatory and internal quality standardsPrepare and maintain validation documentation including protocols reports and standard operating procedures (SOPs)Collect and analyze data during qualification activities to support validation conclusionsIdentify and document deviations and assist in resolution and corrective actionsEnsure validation activities are completed according to established schedules and project timelinesCollaborate with cross-functional teams including quality engineering and operations to align on validation deliverablesMaintain audit-ready documentation and support internal and external inspectionsSupport change control assessments and evaluate the impact of changes on validated systemsParticipate in continuous improvement initiatives to enhance validation processes and documentation practicesEnsure adherence to cGMP FDA EMA and other applicable regulatory requirementsRequirements7 years of hands-on experience in validation roles across pharmaceutical and biopharmaceutical environmentsStrong commitment to quality assurance and precision in executionExtensive knowledge of validation processes and lifecycle managementThorough understanding of global regulatory frameworksProficient in navigating quality systemsEffective communication and interpersonal skills. Proactive with strong organization time management and project management abilities. Excellent attention to detail with commitment to quality and compliance.Preferred experience in Validation Lifecycle Management Platforms and QMSsAt PSC Biotech many of our projects and clients are located in various regions around the country. Therefore we value candidates who are willing and able to travel as needed for project assignments and client engagements. The ability to adapt to different locations cultures and work environments are essential as it allows our team members to collaborate effectively with clients and colleagues nationally. Must be authorized to work in the US. No C2C at this timeBenefitsOffering a full suite of benefits PSC Biotech is firmly focused on diligently investing in our employees who enable our company to fulfill our mission and achieve success. We want to promote balance so you not only enjoy your work but also have the time and resources to live your life happy and healthy. Medical Dental and Vision - PSC pays 100% of all qualifying employee medical premiums and 50% for qualifying dependents Insurance options for Employee Assistance Programs Basic Life Insurance Short/Long Term Disability and more. 401(k) and 401(k) matching PTO Sick Time and Paid Holidays Education Assistance Pet Insurance Discounted rate at Anytime Fitness Financial Perks and Discounts Adhering to the requirements of Californias law on salary transparency the salary bracket for this role is set between $100000 to $130000 annually. The offered salary may be adjusted based on various factors such as the applicants qualifications skills and professional experience.Equal Opportunity Employment Statement PSC is committed to is committed to a policy of Equal Employment Opportunity with respect to all employees interns and applicants for employment. Consistent with this commitment our policy is to comply with all applicable federal state and local laws concerning employment discrimination. Accordingly the Company prohibits discrimination against qualified employees interns and applicants in all aspects of employment including but not limited to: recruitment interviewing hiring (or failure or refusal to hire) evaluation compensation promotion job assignment transfer demotion training leaves of absence layoff benefits use of facilities working conditions termination and employer-sponsored activities and programs including wellness social and recreational programs. Employment decisions will be made without regard to an applicants employees or interns actual or perceived: race color religion sex (including pregnancy gender identity and sexual orientation) national origin age (40 or older) disability genetic information or any other status protected by law.#LI-TP1 Key Skills Python,SOC,Debugging,C/C++,FDA Regulations,Minitab,Technical Writing,GAMP,OS Kernels,Perl,cGMP,Manufacturing Employment Type : Full Time Experience: years Vacancy: 1 Monthly Salary Salary: 100 - 130