Validation and Technical Documentation Writer - Remote

PharmaLogic is the fastest-growing SPECT & PET radiopharmaceutical solutions provider and contract development and manufacturing organization (CDMO) with radiopharmacies across North America. We are passionate about expanding the power of radiopharmaceutical technology to provide transformative diagnostic and therapeutic agents to patients from bench to bedside.PharmaLogic offers you an exceptional opportunity to join our dynamic team as a Validation and Technical Documentation Writer.Role Summary:The Validation and Technical Documentation Writer will play an essential role in generating Standard Operating Procedures (SOPs), Validation Protocols, and Technical Reports to uphold regulatory compliance and ensure the quality and safety of radiopharmaceutical manufacturing processes.Job Responsibilities and Duties: Develop and maintain detailed Standard Operating Procedures (SOPs), Protocols, and Technical Reports for validation activities within a Radiopharmaceutical manufacturing environment. Write and review validation protocols and reports for equipment, processes, and analytical methods, ensuring alignment with regulatory requirements. Collaborate closely with cross-functional teams including Quality Assurance, Manufacturing Operations, Technical Operations, and Engineering to gather necessary information to support the document lifecycle from creation through routine revision. Stay current with FDA regulations, ICH guidelines, and industry standards related to the manufacture of Radiopharmaceuticals and Analytical Instrumentation. Assist with improvement of current GMP and non-GMP processes. Maintain accurate production and test/validation results. Effectively communicate all issues related to safety, quality, and compliance to Quality Assurance and leadership. Perform other job-related duties as assigned. Job Requirements │ Education: Advanced degree in a scientific or technical discipline (Chemistry, Biological Sciences, Nuclear Engineering) preferred. Bachelor’s degree required with 4-5 years of proven experience within a pharmaceutical or research industry. Experience in a GMP, GLP, or GCP environment is preferred. Strong preference will be given to radiopharmaceutical industry experience. Experience with laboratory methodology (HPLC, GC, TLC, and ICP) and aseptic technique highly favored. Strong preference will be given to applicants with experience with automated synthesizers in pharmaceutical manufacturing. Superior teamwork, multi-tasking, and time/project management skills. Excellent communication, analytical, problem solving, presentation and computer skills (including proficiency in Microsoft Office and related software). Experience with document control systems and software (e.g. Master Control) preferred. This position may involve occasional travel to visit company locations as needed. Preference will be given to candidates with life science or pharmaceutical degrees or experience. Physical & Intellectual Requirements: Prolonged periods of sitting, standing, and walking long distances. Must be able to lift up to 15 pounds at times Ability to analyze situations, set priorities and meet deadlines while maintaining attention to detail in a fast-paced and dynamic environment. Demonstrate effective organizational skills; commitment to continuous learning; an ability to work well both independently and as part of a team are required. Come join our winning team and begin a fulfilling career with us by applying today.PharmaLogic is an Equal Opportunity Employer.All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status, or any other protected class.Benefits Include:401(k) retirement benefit programMedicalDental careDisability insuranceEmployee assistance programLife insuranceOn-site parkingPaid time offVision care