CSV Specialist (Onsite / St. Joseph, MO) Position Available In Wake, North Carolina

For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs. •No 3rd-party submittals•Validation documentation Authoring (validation plans, user requirements specifications, risk assessment, IQ-OQ-PQ protocols, trace matrix and summary reports) Experience in validating GMP Lab systems and Equipment o Responsible for assuring a system/application meets its requirements as outlined in system specification (URS/FRS) per process defined in the Validation Plan for the project. Identify and escalate, as necessary project risks and issues to the CSVC Manager. o Engage in multiple CSVC projects through the assimilation of data, establishing facts and drawing valid conclusions to deliver results in accordance with resources, constraints and business needs. Be able to prepare reports on defects and problems that arise during system testing. Have solid oral and written communication skills and teamwork skills. Be a good team player, able to meet deadlines and handle changing priorities. o Have strong judgment capabilities to clarify requirements when necessary. Have the ability to work with cross functional teams o Have solid experience working with validated systems. Work with business representatives to ensure the test cases reflect business rules and processes. Fulfills a subject matter expert role(s) for critical quality and compliance GxP end-use applications supporting Animal Health business processes.

Required Experience:

GMP/Regulated lab, more than 5 years of CSV experience required. Technical writing Experience Highly skilled in Computerized System testing and validation in the healthcare industry. Knowledge of GxP regulations (e.g. 21 CFR Part 11, Annex 11) Solid project organizational skills. Ability to multi-task. Must have strong analytical problem-solving skills. Excellent communication including written, verbal, and listening skills. Self-motivated, detail oriented, takes initiative and ability to work independently without close supervision. Education BS in Science or Technical Writing Degree We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed. •ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.•Don’t see an open opportunity that matches your qualifications? Join our talent community to stay connected for potential future opportunities. Upload your resume/CV and contact details for our Talent Acquisition team to review and match for potential future opportunities. While you are here, sign up for Job Alerts to receive alerts of future opportunities that match your selected interests. To change the language, click on “English” at the top right corner of the screen and select your preferred language. If you are already signed in, click the cloud icon and go to Change Language. ProPharma will never ask you for any bank account information, financial information, or another form of payment to be considered for a role. Additionally, the ProPharma talent acquisition team will only use their work email addresses (domain@propharmagroup.com). If you receive recruiting communications from anyone with a yahoo.com, gmail.com, live.com, propharmagroupjobs.com, or any other email account, it’s likely a fraud. Are you currently a ProPharma colleague? To be considered for an opportunity, please apply through the Jobs Hub in Workday.