Job Details

ID #6040296
Estado Carolina del Norte
Ciudad Monroe
Tipo de trabajo Permanent
Salario USD $75000.00 - $95000.00 per annum 75000.00 - 95000.00 per annum
Fuente Manpower Engineering
Showed 2020-11-23
Fecha 2020-11-23
Fecha tope 2021-01-22
Categoría Etcétera
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Sr. Validation Specialist

Carolina del Norte, Monroe, 28111 Monroe USA

Vacancy caducado!

Glenmark is actively seeking a Sr. Validation Specialist to join its growing team in Monroe, NC! This position is for an individual contributor to the Validation Department with an emphasis on Equipment Qualification. Additional responsibilities include but are not limited to: Cleaning, Critical Utilities, Facilities, and Process Validation. Reporting into the Validation Manager, the Validation Specialist has responsibilities for all aspects of planning, coordination, development, execution and close out of commissioning, qualification and/or validation protocols/reports meeting quality and schedule expectations. As the Sr. Validation Specialist, you will perform installation and operational and performance qualification (IQ/OQ/PQ) of critical manufacturing equipment, facilities, and utility systems for Sterile Manufacturing facilities. Key Responsibilities The position requires knowledge of cGMP and associated industry and regulatory guidance documents. The candidate must have demonstrated proficiency in project management skills and must be able to balance multiple priorities. Main responsibilities include: Equipment Qualification - development of validation protocols, testing execution and writes validation reports. This includes FATs, URSs, DQs, SATs, CTPs, IQs, OQs, PQs, and other validation life cycle document. Cleaning and Process Validation assists/performs cleaning and process validation at the site. Adhere to all company and GMP procedures, along with safety regulations within the plant. Assist with the Site Change Management Program to keep all finished products, equipment, processes and facilities in compliance with contemporary industry standards and regulatory filings. Develop a strong documentation package, involving pre-commissioning/commissioning of equipment, Qualification and documentation Conduct regular project review meetings within the team, with cross functional teams and with the vendors to control the project time to time. Stay current with industry qualification trends through FDA, ISPE, EU, PDA and bench marked companies. Education Bachelors degree required, preferably in Engineering, Chemistry, Microbiology, or Pharmaceutical Sciences A combination of education and relevant experience will be considered. Experience Minimum of eight (8) years of relevant validation experience in the pharmaceutical industry. Demonstrated experience and a high level of experience validating a wide range of equipment and processes in Sterile production environments (cleaning processes, sterile filling, freeze drying, depyrogenation, parts & vial washers, wet/steam/dry heat sterilization, pre-filled syringe filling, vial filling, Nebulizer filling, and packaging). Demonstrated working knowledge of FDA and CFR regulations, and other applicable industry regulations and standards Demonstrated experience and knowledge of qualifying changes to validated systems/processes/and equipment. Strong Knowledge and understanding of validation and qualification principles, and Quality Systems principles (Change Control, Non-Conformance and CAPA). A solid base and application experience in sterile pharmaceutical manufacturing plants, and/or related environmental projects, material handling, containment, and utility/infrastructure support facilities. Strong understanding of aseptic techniques, gowning techniques, assembly of aseptic processing lines and room classifications is required.

Vacancy caducado!

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