JOB SUMMARY:The Technical Services / Validation Specialist will provide direct technical and validation support (including creation of Master Batch Records and Validation Documents) to Engineering, Operations and the Quality Unit, in order to achieve the reliable and compliant packaging of drug products, nutritional supplements, and medical devices. This position reports directly to the EHS Manager.

　　PHYSICAL / MENTAL DEMANDS

　　Job is a mixture of sedentary work and periods of light work (Movement of materials less than 50lbs) as required.Frequent standing, occasional walking, pushing, pullingOccasional travel to support validation projects.Frequent bending, stooping and reaching and climbing of stairs.Employee must be able to receive, understand, and communicate verbal and written instruction and communicate in the English language.Ability to count, draft, read and distinguish numbers and symbols from schedules.SPECIFIC DUTIES, ACTIVITIES AND RESPONSIBILITIES:

　　Provide direct technical and validation support in order to achieve the reliable and compliant packaging of drug products, nutritional supplements, and medical devices via the use of validated equipment and manufacturing processes, work instructions, and procedures.Create Master Batch Records based upon guidance from the Project Management Department.Create protocols associated with packaging, repackaging, and kitting operationsManage and perform the validation program for the Solid Dose Division in the Tennessee location.Perform or assist in the required cGMP packaging and process validations.Write protocols and reports associated with the process validation. Co-ordinate protocols and reports written by other departments. Supervise execution of protocols.Manage the qualification and validation of equipment, facilities and utilities, as well as cleaning, and packaging processes.Attend and participate in process team meetings for production issues, resolution and process improvements.Review and approve validation reports and presenting the validation approach and study results to peers and mangers.Support and maintain validation master schedule.Participates in the development and implementation of internal validation policies/ standards and procedures (equipment, utilities, cleaning and process) ensuring processes and systems meet regulatory agency validation requirements, and current industry practices.Assure the validation program is in adherence to the policies and procedures.Participates in the development, implementation and adherence to Standard Operating Procedures relating to validation and validated processes, making recommendations for changes and/or improvements.Prepares summary validation trend reports for periodic reviews as part of system and equipment lifecycles.Collaborates and conducts cross-functional validation impact assessments for changes to system and equipment.Supports other departments in any corrective actions, regulatory inspections and validation changes.QualificationsQUALIFICATIONS:

　　Bachelors Degree in Chemistry, Microbiology, Engineering or any appropriate scientific discipline. Courses related to medical device, or cGMP preferred.Preferred Minimum five years working in a FDA/GMP manufacturing environment.Proven work record with good working knowledge of Current Good Manufacturing Practices pertaining to medical devices and pharmaceuticalsKNOWLEDGE / SKILLS REQUIREMENTS:

　　Ability to interface and train all levels within the organization.

　　Ability to prioritize assignments.

　　Ability to manage multiple projects in a time sensitive environment.

　　Ability to interact with customers, vendors on an as needed basis.

　　Proven analytical, problem solving and troubleshooting skills.

　　Excellent knowledge of Current Good Manufac uring Practices pertaining to medical devices, drug and pharmaceuticals.

　　Knowledge of process validation activities.

　　Ability to generate flow charts and graph data.

　　Must work in a team environment (Successfully work with diverse people and opinions.)

　　Strong written and oral communication skills. (Ability to report on changes in standards and on performance against standards).

　　Results oriented (Ability to measure performance against established standards).

　　Working knowledge of Standard Operating Procedures (SOPs)

　　Flexibility to effectively respond to changing work requirements and challenges.

　　PC familiarity with Windows operating systems; particularly excel and word. Functional use of internet and email. Also, must have a familiarity with internal software use in the quality function.

　　Be able to work independently and autonomously

　　Working knowledge of GMPs

　　Working knowledge of validation and using risk-based approach (FMEA, PHA, etc.).

　　Ability to read/interpret engineering drawings and design documents.

　　Knowledge of Validation Lifecycle Approach (e.g. ASTM E2500)

　　Conducting statistical analysis of validation test results.

　　Working knowledge of ICH Q8, Q9, Q10 and other international regulatory requirements.

　　Investigation / trouble shooting validation problems.