U.S. Electronics, Inc.
Location
Hyderabad | India
Job description
Job Title: Equipment Validation Specialist
We are looking for eligible candidates for H1 filling for FY 2025. Interested candidates should have specialty skills and real time experience. Please provide us your resume with contact details. Also, please refer your friends who are looking for H1B visa filling. Position Overview: As an Equipment Validation Specialist, you will be responsible for ensuring the proper validation of various equipment used in our pharmaceutical manufacturing facilities. This role involves collaborating with cross-functional teams, developing validation protocols, and executing validation activities to meet regulatory standards and ensure the reliability and integrity of our manufacturing processes. Responsibilities: Lead and execute equipment validation activities for a range of critical manufacturing equipment, including but not limited to: Autoclaves High-performance liquid chromatography (HPLC) systems Lyophilizers Tablet presses HVAC systems Collaborate with Engineering, Quality Assurance, and Manufacturing teams to ensure equipment is validated in accordance with regulatory requirements and company policies. Conduct risk assessments and impact analyses to identify and address potential validation issues related to specific equipment. Perform equipment qualification and validation studies for diverse equipment types to ensure compliance with cGMP guidelines and other relevant regulatory standards. Develop and maintain validation documentation, including protocols, reports, and standard operating procedures (SOPs) specific to each equipment type. Provide support during regulatory inspections and audits related to the validation of equipment. Participate in equipment change control processes to assess and manage the impact on validation status. Keep abreast of industry trends, regulatory changes, and best practices in equipment validation. Qualifications: Bachelor's OR Master's degree in a relevant scientific or engineering discipline. Minimum of 5 years of experience in equipment validation within the pharmaceutical industry. Strong knowledge of FDA regulations, cGMP guidelines, and other relevant industry standards. Excellent communication skills, both written and verbal, with the ability to convey technical information clearly and concisely. Proven ability to work collaboratively in a cross-functional team environment. Detail-oriented with strong analytical and problem-solving skills. Experience with risk assessment methodologies and validation lifecycle management. Familiarity with validation software and tools.Job tags
Salary
