Job Postings

Job Title —Validation Specialist

Company —Vastek Inc.

Location —San Diego, California.

Job Description:(VAStek Inc. has openings in San Diego, CA) Validation Specialist: Perform Equipment, Instrument, Cleaning and Process Validation in the pharmaceutical industry. Execute equipment calibration, preventative maintenance, performance verification, and repair activities in laboratory and manufacturing areas. Review and approve vendor executed calibration, maintenance, repair, and performance verification records for accuracy, completeness, and compliance to client standards. Work closely with and enter data into the site CMMS system. Ensure calibration, PM, and performance verification records are filed appropriately after approval. Write and support deviations and investigations that result from calibration or performance verification failures. Develop and support the implementation of corrective and preventative actions. Support the development, revision, and review of written procedures for calibration, preventive maintenance, and performance verification of equipment. Support the development, review, and approval of calibration and maintenance plans in the site CMMS system. Support the execution of equipment performance verification and process improvement studies. Review, prioritize, and promptly respond to customer equipment performance verification and support requests. Provide technical support and guidance on calibration, equipment performance verification, and validations issues. Work with planning groups to ensure the system is updated as calibration, maintenance, and performance verification activities are performed. Maintain all required Corporate, Facilities, and EHS training. Adhere to safety procedures and hazard communication. Act as SME in internal and regulatory audits. Will work in various unanticipated locations throughout the U.S.

Requires Bachelor’s in Pharmaceutical Sciences, Chemistry, Engineering, or related and 1 year experience. $78,208.00 per year.

Send resume to and refer to job title to swapna@vastekgroup.com .

Job Title —Training and Development Manager

Company —Vastek Inc.

Location —San Diego, California.

Job Description:(VAStek Inc. has an opening in San Diego, CA) Training and Development Manager: Manage, organize, and facilitate training and development workshops in the pharmaceutical field. Oversee the design and implementation of a training program to certify employees on the latest EU and U.S. FDA medical products and Pharma regulations through the company’s Learning Management System. Assess training needs and modify programs as needed. Review learning materials to support employees with building Validation, FDA, GMP, ICH, and ISO technical skills. Manage the company-wide mentorship program including validation training, facilitate discussion sessions in the Pharma/Biotech industry, and educate employees on FDA regulations and other international guidelines.

Requires Master's in Pharmaceutical Sciences, Chemistry, Engineering, or related and 3 years experience. $138,590.00 per year.

Send resume to and refer to job title to swapna@vastekgroup.com .

Job Title —Regulatory Affairs Specialist CMC

Company —Vastek Inc.

Location —San Diego, California.

Job Description:(VAStek Inc. has openings in San Diego, CA) Regulatory Affairs Specialist CMC: Provide regulatory filing requirements, submission strategy, and regulatory risk assessments in support of CMC development of early-stage cell and gene therapy products. Prepare regulatory filings and identify issues and factors that may impact a regulatory strategy or activity. Support development of high quality, compliant, and timely regulatory submissions that require extensive interaction with departments outside of Regulatory Affairs and CTMC. Ensure submission readiness at the document-level, including document formatting and PDF generation, bookmarking, and hyperlinking. Compile, publish, and submit in eCTD via the Electronic Submissions Gateway. Monitor and provide data to be entered into tracking systems for department deliverables and ensure information is current. Evaluate change proposals for regulatory impact and support CMC information amendments. Will work in various unanticipated locations throughout the U.S.

Requires Bachelor’s in Pharmaceutical Sciences or related. $70,762.00 per year.

Send resume to and refer to job title to swapna@vastekgroup.com .