Technical Specialist (Validation)

We are a leading world supplier of integrated processing solutions for customers in the area of pharmaceuticals food processing feeds and fine chemicals. Our products and services stand for reliability and quality worldwide. About 3000 employees work for Glatt at more than 15 companies and offices all over the world. For our site in Ramsey NJ USA we have an immediate opening for aTechnical Specialist ValidationAccountability The roles primary accountability is to ensure that all validation activities are executed with scientific rigor and in full compliance with regulatory and company standards thereby supporting robust pharmaceutical manufacturing and ensuring patient safety.Essential Job FunctionCreate manage and oversee the generation of technical documents in support of Pharmaceutical Development Manufacturing Operations Facilities Quality Assurance and Quality Control. Technical documents may include Standard Operating Procedures CAPAs OOS Equipment Qualification Process and Cleaning Validation protocols and reports for the Pharmaceutical Services Division of GAT. Qualifications and Skills· BABS degree or certificate in a technology related field Biology Chemistry Pharmacy Engineering etc.· Must have at least 5 years of development or manufacturing experience in a cGMP solid dosage manufacturing environment with the ability to understand the fundamental processing stages required to independently create the protocols change controls investigations deviations and final reports required to conduct equipment qualification process validation and cleaning validation activities.· Should possess a pharmaceutical manufacturingdevelopment and cGMP background in a solid dosage form environment with preferred background in fluid bed processing. · Must be able to demonstrate an understanding of compliance and write well-defined processing stepsinstructions with a logical process flow and an emphasis on Quality processing. Must have the ability to articulate their point clearly and concisely through the power of the written word.· Strong computer skills and proficiency in Microsoft Office suite are a necessity with an ability to accurately convey information in both verbal and written form. Strong command of the English language is essential.· Must be detail oriented and able to meet deadlines. Solid organizational skills are a necessity with a demonstrated ability to organize and track several projects simultaneously. The ability to follow-up with multiple departments is required.· Computer System Validation CSV and Automation Systems knowledge.Responsibilities· Interacts with and coordinates with representatives of technical associates project leads customers and subject matter experts from other departments internally and externally to create Process Cleaning and Computer Validation ProtocolsReports IQOQPQ documents facility commissioning documents investigations CAPAs change controls product development reports scale up documents etc. with a strong emphasis on the following pharmaceutical processes fluid bed granulation blending milling compression encapsulation coating & packaging.· Maintains updates and utilizes document templates guidelines and other procedures to remain consistent across processes and individual customers to assure a consistent level of cGMP standards for GATs protocols and all IQOQPQ templates that are in alignment with GAT approved master plans. · Supports internal compliance audits of various departments collects relevant data for evaluation examination of documents and records interview with employees tour andor observation of work in progress analyzes the information collected and determines the compliance status of the audited area to that of the required performance standards. · Supports the department Head for all process cleaning and computer equipment validation activities for the site.· Prepares andor updates divisional departmental SOPs where applicable initiating change request and the preparation of any forms or attachments that may accompany the SOP.· Researches and understands new equipment through user manuals to create IQOQPQ documents for equipment qualification program.· Creates and executes cleaning validation verification protocols and produces follow-up reports. Maintains accurate documentation for the cleaning validation program at GAT. Coordinates with the Planning department and routinely reviews the manufacturing schedule to inform the cleaning validation verification activities.· Creates equipment facilities and systems commissioning and qualification protocols and reports.· Other tasks as assigned by Management.Salary starting at 75000You have the opportunity to perform an interesting and responsible job in a successful renowned company.If this interesting position appeals to you we look forward to receiving your online application.Applications that do not reach us personally via the online portal can unfortunately not be considered.Glatt Air Techniques Inc. Human Resources 20 Spear Road Ramsey NJ 07446 USA www.glatt.com