Validation Associate

The Validation Associate plays a key role in ensuring that equipment, processes, and cleaning procedures consistently meet regulatory, quality, and operational standards within a pharmaceutical manufacturing environment. This position conducts a variety of validation studies and inspections, supports environmental monitoring and cleaning validation, and helps maintain compliance with current Good Manufacturing Practices (cGMP), FDA regulations, and internal Standard Operating Procedures (SOPs). The role requires strong analytical skills, attention to detail, and effective collaboration with cross-functional teams to support reliable and compliant production processes. Responsibilities Conduct performance qualification tests to verify equipment performance, including homogeneity studies and assessments of consistency in producing reliable results. Perform environmental monitoring activities, including executing temperature mapping studies to evaluate temperature distribution within equipment and identify potential areas of concern. Execute validation studies to ensure adherence to regulatory requirements, cGMP standards, and established SOPs. Update and revise Standard Operating Procedures (SOPs) to reflect current practices, regulatory expectations, and industry standards. Perform cleaning validation procedures to confirm compliance with sanitation guidelines and ensure equipment and areas are appropriately cleaned for manufacturing use. Perform equipment operation qualification tests by assessing flow rates, temperature settings, and other critical parameters to confirm proper functioning. Collect samples for submission to the laboratory for analysis and perform data entry of deviations, ensuring that all information is accurate, complete, and compliant with established SOPs. Review validation and monitoring data to ensure accuracy, completeness, and compliance with regulatory and internal quality standards. Verify the proper installation of equipment by conducting thorough inspections and assessments to ensure compliance with regulatory and company standards. Proactively seek opportunities for process improvements and recommend changes to enhance operational efficiency in validation procedures and quality control activities. Perform various validation inspections, cleaning activities, checks, and tests during the manufacturing process to support consistent product quality. Compile, interpret, and record observations of production processes to support validation protocols and continuous improvement efforts. Identify and communicate issues or deviations related to validation, and assist in the execution of various validation protocols to resolve them. Collaborate with cross-functional teams in chemistry, biology, quality assurance, quality control, and pharmaceutical manufacturing to support equipment validation and aseptic techniques. Ensure all validation activities align with FDA expectations, cGMP requirements, and internal quality assurance standards. Bachelor’s degree required, preferably in Chemistry, Biology, Engineering, Microbiology, or Forensic Sciences. Validation experience preferred, including exposure to equipment validation and validation protocols in a manufacturing or pharmaceutical setting. Knowledge of current Good Manufacturing Practices (cGMP), FDA regulations, and manufacturing practices to ensure regulatory compliance preferred. Demonstrated experience, proficiency, knowledge, or training in a regulated cGMP, manufacturing, or pharmaceuticals environment preferred. Strong oral and written communication skills with close attention to detail and accuracy to collaborate effectively with cross-functional teams and communicate findings and recommendations. Strong organizational, critical thinking, reasoning, and problem-solving abilities to evaluate data, identify issues, and support continuous improvement. Proficiency in Microsoft Office programs for data analysis, documentation, reporting, and communication. Ability to follow and interpret SOPs, validation protocols, and regulatory guidelines accurately. Comfort working with chemistry, biology, quality assurance, quality control, and aseptic techniques in a pharmaceutical manufacturing context. Additional Skills & Qualifications Experience in pharmaceutical manufacturing or biopharmaceutical environments is highly beneficial. Familiarity with quality assurance and quality control principles and practices. Understanding of aseptic techniques and clean room practices. Ability to compile, interpret, and document observations of production processes in a clear and organized manner. Experience supporting or executing cleaning validation and environmental monitoring programs. Comfort working with validation protocols and documentation in a regulated environment. Interest in continuous improvement and process optimization within validation and quality control functions. This role operates primarily in an air-conditioned office environment with regular work in clean room areas associated with pharmaceutical manufacturing. The position may involve exposure to extremely cold temperatures when working with certain equipment or storage areas. Work is performed in controlled, regulated spaces designed to meet cGMP and FDA requirements, with a strong emphasis on cleanliness, aseptic technique, and adherence to SOPs. Collaboration with laboratory, manufacturing, and quality teams is routine, and tasks involve both desk-based documentation and on-floor inspections, monitoring, and testing. Job Type & Location This is a Contract to Hire position based out of Boca Raton, FL. Pay and Benefits The pay range for this position is $32.69 - $33.65/hr. Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors. Eligibility requirements apply to some benefits and may depend on your jobclassification and length of employment. Benefits are subject to change and may besubject to specific elections, plan, or program terms. If eligible, the benefitsavailable for this temporary role may include the following: Medical, dental & vision Critical Illness, Accident, and Hospital 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available Life Insurance (Voluntary Life & AD&D for the employee and dependents) Short and long-term disability Health Spending Account (HSA) Transportation benefits Employee Assistance Program Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in Boca Raton,FL. Application Deadline This position is anticipated to close on Oct 5, 2026. Equal Opportunity Employer The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email View email address on click.appcast.io for other accommodation options. #J-18808-Ljbffr The Visual Group, LLC