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It's our way of thinking about helping our family of team members grow.
Work location is Plainsboro, NJ with required travel to client locations throughout the USA based on client assignments. Please mail resumes to 666 Plainsboro Road, Suite 1236, Plainsboro, NJ 08536 (or) e-mail : hari@sathramcorp.com
Regulatory Affairs Specialist
Regulatory Affairs Specialist with Master’s degree in Technology, Proj Mgmt, Any Analytical Science or related to perform acceptance review and comprehensive substantive review of the 510(k) submissions to ensure it is administratively complete and scientifically complies with the FDA regulations and guidelines. Submit notifications to J&J Regulatory Affiliates pertaining to changes to Product, Manufacturing, Quality, Packaging and Labeling. Provide solutions to a variety of problems of moderate scope of complexity.
Clinical Trial Manager
Sathram Corporation has openings for the position Clinical Trial Manager with Master’s degree in Public Health or related and 1 yr of exp to work on development of study synopsis, protocols, and protocol amendments, IB, CSR. Responsible for managing and creating trial related plans such as communication plan, project oversight plan, monitoring plan,TMF Plan, Data Management Plan, SOP’s. Involve in reviewing essential documentation related to clinical studies ensuring. Involve in the creation of study preparation materials for investigator meetings, site training, meetings. Manage all clinical aspects of study, including: managing study timelines and metrics; participates in selection and management/oversight of external vendors; reviews vendor reports, budgets, and metrics.
Validation Engineer
Posted on 13th March, 2024
Apply for the job & join Sathram family.
Validation Engineer with Master’s degree in Computer Science, Engineering any, Technology or related and 1 yr of exp to analyze validation data, prepare reports including preparation of standard operating procedures by adhering to FDA, cGMP standards. Develop and execute of Validation plans (VP), Validation Protocols (IQ, OQ and PQ),GxP assessment, Requirement Traceability Matrix (RTM) and Summary Reports (Validation summary reports VSR) and develop Standard Operating Procedures (SOPs).Perform GAP Analysis, Remediation Plan and maintenance of hybrid systems, close and open record systems in cleaning validation.
Regulatory Affairs
Posted on 13th March, 2024
Apply for the job & join Sathram family.
Regulatory Affairs with Master’s degree in Regulatory Affairs or related to work on establishing Dossier Plans for the assigned submission types / projects considering inputs from functional area representatives and key stakeholders. Maintaining effective interactions with relevant stakeholders and other RSMO colleagues as appropriate to ensure priority conflicts, resource issues and deviations from the plans are identified and resolved. Ensuring relevant submission process(es) are applied to all assigned submissions, including coordinating the electronic component and dossier level publishing and production of regulatory submissions that conform to regional and country specific regulatory requirements as appropriate.
Software Validation Engineer
Software Validation Engineer with Master’s degree in Computer Science, Engineering, Technology, or related and 6 months of exp to meet health authorities’ regulations and requirements. Develop Requirements Specification, IT System builds specifications, Software Design Specifications, System Architecture, and Configuration Specifications for Enterprise IT systems and cloud-based computerized systems and applications. Validate Infrastructure including Infrastructure as a Service (IaaS), Platform as a Service (PaaS), and Software as a Service (SaaS). Develop a Test Strategy and plan to execute testing for configuration and customization done to the system to meet user requirements. Develop SQL Scripts to validate the source data with respect to the application data. Perform GAP Analysis, Remediation Plan, and maintenance of hybrid systems, close and open record systems in cleaning validation.
Validation Specialist
Validation Specialist with a master’s degree in computer science, Engineering, Technology, Any Analytical Science, Health Informatics, or related in developing process flow diagrams and execution of process and product FMEA risk analysis. Authoring qualification-related documents for pharmaceutical and laboratory equipment such as IQ, OQ, and PQ. Creation of validation package and coordination with QA for document archival and audit preparation. Execute validation plans, requirement specifications, and validation protocols including installation, operation, and performance qualification.
Validation Engineer
Posted on 16th Jun , 2024
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Validation Analyst
Validation Analyst with bachelors’ degree in Engineering(any),Microbiology, Technology or related and 2 yrs of exp to execute validation plans, requirement specifications and validation protocols including installation, operation and performance qualification (IOPQ). Prepare or revise validation protocols/procedures as required. Ensures that all regulatory and cGMPs compliance items related to validation are satisfied and ensures Validation Master Plan (VMP) adherence. Drafting, reviewing, receipt and addressing of comments to approve validation documentation in compliance with FDA and company guidelines. Review and approve manufacturing operational use SOPs that apply to validated equipment and processes. Analysis of study data using statistical/analytical software systems to present in summary reports and with cross functional teams to determine.
Clinical Trial Lead
Clinical Trial Lead with Master’s degree in Biological Science, Any Analytical Science, Technology any or related and 1 yr of exp to work collaboratively with Clinical Scientist, Clinical Indication/Development Lead, and clinical study team to ensure ongoing review of patient profiles and data listings. Participates in the development and review of department SOPs and process improvement initiatives. Responsible for the completeness of documents managed in the electronic Trial Master Files (TMF); perform ongoing reviews of TMF to assure quality of the documentation files and compliance with SOPs, GCP and ICH Guidelines. Supporting CPMs with various study start-up activities including tracking investigator site feasibility status, essential documents review for the site initiation and investigational product release and enrollment. Manages monitoring oversight of site-level activities related to ongoing and planned trials. Develops and manages detailed strategies and documentation and provides regular study status updates to senior management. Effectively manages third-party suppliers for contracted deliverables within quality, cost, and timeline parameters. Provides coaching/mentoring to assigned program and site staff (CRAs, and CRCs) by demonstrating leadership competencies.
It's our way of thinking about helping our family of team members grow.
Work location is Plainsboro, NJ with required travel to client locations throughout the USA based on client assignments. Please mail resumes to 666 Plainsboro Road, Suite 1236, Plainsboro, NJ 08536 (or) e-mail : hari@sathramcorp.com
Compliance Manager with Master’s degree in Engineering (any), Buss Admin, Life Sci, or related scientific/quantitative discipline or related and 1 year of exp to Create innovative and integrated programs, aligning with overall business strategies. Implement FDA-regulated biotechnology or drug development requirements including, FDA 21 CFR Parts 11, 820, GCP, ICH, HIPPA, and CDISC standards. Provide expert guidance and direction of the Quality Systems to a team of Quality specialists responsible for developing, establishing, and maintaining quality systems programs, processes, procedures, training materials, and controls enhancing, the performance and quality of products and the divisional capability to demonstrate conformance to established standards and agency regulations/audits including cGMP, GCP, ICH compliance, clinical, and other activities. Review new and revised regulations/standards/guidelines, determining and interpreting content and implications with business partners to assess the impact on clinical trial conduct and associated processes. Drive discussions with business partners during procedural or process changes to ensure regulatory requirements are understood and maintained.
Work location is Plainsboro, NJ with required travel to work from various unanticipated client worksites throughout the USA.
Please mail resumes to 666 Plainsboro Road, Suite 1236, Plainsboro, NJ 08536 (or) e-mail : Rmkamineni@sathramcorp.com
Compliance Manager with Master’s degree in Engineering (any), Buss Admin, Life Sci, or related scientific/quantitative discipline or related and 1 year of exp to Create innovative and integrated programs, aligning with overall business strategies. Implement FDA-regulated biotechnology or drug development requirements including, FDA 21 CFR Parts 11, 820, GCP, ICH, HIPPA, and CDISC standards. Provide expert guidance and direction of the Quality Systems to a team of Quality specialists responsible for developing, establishing, and maintaining quality systems programs, processes, procedures, training materials, and controls enhancing, the performance and quality of products and the divisional capability to demonstrate conformance to established standards and agency regulations/audits including cGMP, GCP, ICH compliance, clinical, and other activities. Review new and revised regulations/standards/guidelines, determining and interpreting content and implications with business partners to assess the impact on clinical trial conduct and associated processes. Drive discussions with business partners during procedural or process changes to ensure regulatory requirements are understood and maintained.
Work location is Plainsboro, NJ with required travel to work from various unanticipated client worksites throughout the USA.
Please mail resumes to 666 Plainsboro Road, Suite 1236, Plainsboro, NJ 08536 (or) e-mail : Rmkamineni@sathramcorp.com
Software Validation Engineer with Master’s degree in Computer Science, Engineering, Technology, or related and 6 months of exp to meet health authorities’ regulations and requirements. Develop Requirements Specification, IT System builds specifications, Software Design Specifications, System Architecture, and Configuration Specifications for Enterprise IT systems and cloud-based computerized systems and applications. Validate Infrastructure including Infrastructure as a Service (IaaS), Platform as a Service (PaaS), and Software as a Service (SaaS). Develop a Test Strategy and plan to execute testing for configuration and customization done to the system to meet user requirements. Develop SQL Scripts to validate the source data with respect to the application data. Perform GAP Analysis, Remediation Plan, and maintenance of hybrid systems, close and open record systems in cleaning validation.
Work location is Plainsboro, NJ with required travel to client locations throughout the USA based on client assignments. Please mail resumes to 666 Plainsboro Road, Suite 1236, Plainsboro, NJ 08536 (or) e-mail : hari@sathramcorp.com
Posted on 23rd Oct, 2024
Compliance Manager:
Apply for the job & join Sathram family.
Work location is Plainsboro, NJ with required travel to work from various unanticipated client worksites
throughout the USA.
Regulatory Affairs Specialist with Master’s degree in Technology, Proj Mgmt, Any Analytical Science or related to perform acceptance review and comprehensive substantive review of the 510(k) submissions to ensure it is administratively complete and scientifically complies with the FDA regulations and guidelines. Submit notifications to J&J Regulatory Affiliates pertaining to changes to Product, Manufacturing, Quality, Packaging and Labeling. Provide solutions to a variety of problems of moderate scope of complexity.
Work location is Plainsboro, NJ with required travel to client locations throughout the USA based on client assignments. Please mail resumes to 666 Plainsboro Road, Suite 1236, Plainsboro, NJ 08536 (or) e-mail : hari@sathramcorp.com
SATHRAM CORPORATION has openings for the position of Drug Safety Specialist with Master’s degree in Chemistry, Pharmacy or related and 6 months of exp to participate in inspections and audits as identified, including interviews and provision of requested data. Case processing of individual case safety reports (ICSR) from clinical and post marketing sources. Responsible for coding medical history, adverse events and drugs according to the appropriate dictionary like MedDRA, Company Product Dictionary, WHO-DD. Evaluate the seriousness, causality, and expectedness of adverse events, conduct quality control of non-serious and serious cases. Ensure compliance with regulatory requirements for reporting timelines and documentation. Preparation of standard operating procedures (SOP’S) process related documents and product guidance documents.
Work location is Plainsboro,NJ. Please mail resumes to 666 Plainsboro Road, Suite 1236, Plainsboro, NJ 08536 (or) e-mail : hari@sathramcorp.com
Posted on 14th April, 2024
Regulatory Affairs:
Apply for the job & join Sathram family.
Sathram Corporation has openings for the position Clinical Trial Manager with Master’s degree in Public Health or related and 1 yr of exp to work on development of study synopsis, protocols, and protocol amendments, IB, CSR. Responsible for managing and creating trial related plans such as communication plan, project oversight plan, monitoring plan,TMF Plan, Data Management Plan, SOP’s. Involve in reviewing essential documentation related to clinical studies ensuring. Involve in the creation of study preparation materials for investigator meetings, site training, meetings. Manage all clinical aspects of study, including: managing study timelines and metrics; participates in selection and management/oversight of external vendors; reviews vendor reports, budgets, and metrics.
Work location is Plainsboro, NJ with required travel to client locations throughout the USA based on client assignments. Please mail resumes to 666 Plainsboro Road, Suite 1236, Plainsboro, NJ 08536 (or) e-mail : hari@sathramcorp.com
Posted on 19th June, 2024
Validation Engineer:
Apply for the job & join Sathram family.
Validation Engineer with Master’s degree in Computer Science, Engineering any, Technology, Cybersecurity, Chemistry, Any Analytical Science or related to analyze validation data, prepare reports including preparation of standard operating procedures by adhering to FDA, cGMP standards. Develop and execute of Validation plans (VP), Validation Protocols (IQ, OQ and PQ), GxP assessment, Requirement Traceability Matrix (RTM) and Summary Reports (Validation summary reports VSR) and develop Standard Operating Procedures (SOPs). Perform GAP Analysis, Remediation Plan and maintenance of hybrid systems, close and open record systems in cleaning validation.
Work location is Plainsboro,NJ with required to travel and work from various unanticipated client worksites throughout the USA. Please mail resumes to 666 Plainsboro Road, Suite 1236, Plainsboro, NJ 08536 (or) e-mail : hari@sathramcorp.com
Posted on 19th June , 2024
Clinical Trial Lead:
Apply for the job and Join Sathram Family.
Clinical Trial Lead with Master’s degree in Biological Science, Any Analytical Science, Technology any or related and 1 yr of exp to work collaboratively with Clinical Scientist, Clinical Indication/Development Lead, and clinical study team to ensure ongoing review of patient profiles and data listings. Participates in the development and review of department SOPs and process improvement initiatives. Responsible for the completeness of documents managed in the electronic Trial Master Files (TMF); perform ongoing reviews of TMF to assure quality of the documentation files and compliance with SOPs, GCP and ICH Guidelines. Supporting CPMs with various study start-up activities including tracking investigator site feasibility status, essential documents review for the site initiation and investigational product release and enrollment. Manages monitoring oversight of site-level activities related to ongoing and planned trials. Develops and manages detailed strategies and documentation and provides regular study status updates to senior management. Effectively manages third-party suppliers for contracted deliverables within quality, cost, and timeline parameters. Provides coaching/mentoring to assigned program and site staff (CRAs, and CRCs) by demonstrating leadership competencies.
Validation Analyst with bachelors’ degree in Engineering(any),Microbiology, Technology or related and 2 yrs of exp to execute validation plans, requirement specifications and validation protocols including installation, operation and performance qualification (IOPQ). Prepare or revise validation protocols/procedures as required. Ensures that all regulatory and cGMPs compliance items related to validation are satisfied and ensures Validation Master Plan (VMP) adherence. Drafting, reviewing, receipt and addressing of comments to approve validation documentation in compliance with FDA and company guidelines. Review and approve manufacturing operational use SOPs that apply to validated equipment and processes. Analysis of study data using statistical/analytical software systems to present in summary reports and with cross functional teams to determine.
Work location is Plainsboro,NJ with required to travel and work from various unanticipated client worksites throughout the USA. Please mail resumes to 666 Plainsboro Road, Suite 1236, Plainsboro, NJ 08536 (or) e-mail : hari@sathramcorp.com
Posted on 6th Feb, 2025 to 5th March, 2025
Validation Engineer:
Apply for the Job and Join Sathram Family.
SATHRAM CORPORATION has openings for the position Validation Engineer with Master’s degree in Computer Science, Engineering any, Technology, Cybersecurity, Chemistry or related to analyze validation data, prepare reports including preparation of standard operating procedures by adhering to FDA, cGMP standards. Develop and execute of Validation plans (VP), Validation Protocols (IQ, OQ and PQ), GxP assessment, Requirement Traceability Matrix (RTM) and Summary Reports (Validation summary reports VSR) and develop Standard Operating Procedures (SOPs). Perform GAP Analysis, Remediation Plan and maintenance of hybrid systems, close and open record systems in cleaning validation.
Work location is Plainsboro, NJ with required travel to work from various unanticipated client worksites throughout the USA. Please mail resumes to 666 Plainsboro Road, Suite 1236, Plainsboro, NJ 08536 (or) e-mail : Rmkamineni@sathramcorp.com
Posted on 6th March, 2025 to 5th April, 2025
Validation Engineer:
Apply for the Job and Join Sathram Family.
SATHRAM CORPORATION has openings for the position Validation Engineer with Master’s degree in Computer Science, Engineering any, Technology, Cybersecurity, Chemistry or related to analyze validation data, prepare reports including preparation of standard operating procedures by adhering to FDA, cGMP standards. Develop and execute of Validation plans (VP), Validation Protocols (IQ, OQ and PQ), GxP assessment, Requirement Traceability Matrix (RTM) and Summary Reports (Validation summary reports VSR) and develop Standard Operating Procedures (SOPs). Perform GAP Analysis, Remediation Plan and maintenance of hybrid systems, close and open record systems in cleaning validation.
Work location is Plainsboro, NJ with required travel to work from various unanticipated client worksites throughout the USA. Please mail resumes to 666 Plainsboro Road, Suite 1236, Plainsboro, NJ 08536 (or) e-mail : Rmkamineni@sathramcorp.com
