Process Development Validation Scientist – Osmotica Position Available In Cobb, Georgia

Process Development Validation Scientist – Osmotica 3.0 3.0 out of 5 stars Marietta, GA Description The incumbent is responsible for supporting Technology Transfer of pharmaceutical dosage forms and drug delivery systems for new and existing chemical entities according to approved plans/protocols. The Process Development/Validation Scientist is responsible for developing, organizing, and leading development activities on the shop floor and performing validation activities. The Process Development/Validation Scientist also performs related technical writing functions, including Standard Operating Procedures. The incumbent is also responsible for operating the laboratory process and testing related equipment in the Pharmaceutical Sciences Laboratory.

Essential Responsibilities:

Operate complex scientific instruments, mix and assemble compound drugs and perform tests that determine whether liquids, powders or tablets contain the right amount of each ingredient and meet other requirements. Recording production statistics, monitoring equipment operations and assigning tasks to production staff. Supervise manufacturing and/or packaging operations in full cGMP conditions. Assist with preparing laboratory experiments and analyzing results. Leads all phases of validation. With minimal supervision, evaluates projects for validation requirements, determines validation project timelines and priorities, develops protocols, and completes approval, execution and reporting. Provides guidance and technical information to manufacturing technicians. Supports project scope development activities with various related departments, and coordinates with testing participants during all validation activities. Writes SOP’s as new processes are developed and serves as subject matter expert on the assigned areas. Writes, reviews, and approves cGMP documentation including batch records, protocols, SOPS, pharmaceutical development reports, investigation SME statements, and outcomes for development problems, etc. May lead validation activities for projects that can encompass multiple protocols. Authors and reviews new procedures or incorporates changes to existing standard operating procedures describing validation principles, activities and training. Writes and conducts shipping studies at the vendor’s site. Lead member in site validation activities. Works with other departments (QA, Laboratory and Validation) to support site projects. Reviews engineering drawings (P&IDs, construction, as-built, flow diagrams) for accuracy and compliance with GMP/Validation principles and provides feedback to engineering for any noted deficiencies or improvements. Performs and reviews validation testing as required. Reviews validation packets for completeness and accuracy, sound rationale, compliance with validation policies and procedures, and accurate data analysis. Compares results against acceptance criteria and brings exceptions and deviations to management’s attention. Initiates Exception or Incident Reports and resolves discrepancies. Willing to travel to CMOs and vendor sites including internationally. Core Competencies Strong interpersonal and leadership skills necessary to communicate clearly and effectively and coordinate qualification/validation activities with all levels of personnel from various disciplines including Manufacturing Operations, Quality Assurance, Analytical Sciences, Engineering, Facilities, and Regulatory Affairs. Adept at using personal computers and various software programs (e.g., Word, Excel, Project & Minitab), for data acquisition, statistical analysis of validation data and word processing. Proficient in batch record and protocol development, data analysis and report writing. Understanding of statistics and their use in qualification and analysis.

Minimum Qualifications:

Bachelor’s degree in chemistry, engineering, pharmacy or a scientific discipline. Minimum 0-3 years’ experience in the pharmaceutical industry. Experience in manufacturing and packaging operation in a solid dose environment. Expertise in the principles of equipment design/operations and validation of at least 4 of the following: Facilities (including design, material and personal flow analysis, HVAC/HEPA), utilities (including WFI & purified water, clean steam, compressed process air), Clean-In- Place system, solid dosage equipment, process and cleaning validation. Physical and Mental Demands and Work Environment The physical and mental demands and work environment described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. Physical Demands While performing the duties of this job, the employee is regularly required to stand. The employee is frequently required to walk, sit, climb or balance and stoop, kneel, crouch or crawl. The employee is occasionally required to use hands to handle or feel. The employee must regularly lift and/or move up to 25 pounds, frequently lift and/or move up to 50 pounds, and occasionally lift and/or move more than 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus. Mental Demands While performing the duties of this job, the employee is regularly required to use English written and oral communication skills; read and interpret data, information and documents; analyze and solve non-routine office administrative problems; use math and mathematical reasoning; observe and interpret situations; learn and apply new information skills; perform detailed work on multiple, concurrent tasks; work under deadlines with frequent interruptions; and interact with the department staff and others outside the department. Work Environment The employee works under typical office conditions. The noise level in the work environment is usually quiet to moderate. The noise level on the shop floor may require the use of hearing protection. The use of PPE in manufacturing operations may be required. The above statements are intended to describe the general nature and level of work being performed. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of personnel so classified.