Jovan J.
CSV Manager, Technical Engineering
Experience
CSV Manager, Technical Engineering
CureVac Printer GmbH
- Assist with the development of system requirements and specifications to ensure requirements are testable and 21 CFR Part 11 compliant
- Coach implementation teams in the proper execution of validation documents
- Evaluate proposed changes to validated computer systems and recommend the level of validation activities required
- Coordinate audits of internal computer systems validation activities, protocols, and procedures, and prepare responses
- Identify and qualify all computer systems impacting cGMP operations using a risk-based methodology
- Develop CFR Part 11 computer systems validation plans, qualification test protocols, traceability matrices, reports, IQ/OQ protocols, and deliverables within the scope of the validation plan
- Develop and maintain test plans, test scripts, and user acceptance tests, and manage test plan execution
- Act as CSV Lead for all validation projects and oversee execution of validation plans and documents
- Perform project management activities for the CSV process within the scope of overall system projects
- Collaborate with overall project manager to integrate validation activities into implementation timelines
- Manage internal CSV resources to facilitate completion of qualification activities
- Ensure initiation, preparation, and closeout of all CSV-related deviations, discrepancies, and change control documents
- Work closely with Validation Manager and QA Compliance to ensure appropriate validation of cGMP computer systems
- Conduct or facilitate validation and 21 CFR Part 11 training
Formulation and Process Development Senior Specialist, R&D Department
Hemofarm AD (STADA group)
Work on pre-formulation and formulation activities, including selection of primary packaging
Develop processes for new or modified products and transfer them from development to production
Prepare development, registration, and accompanying documentation for new or modified products
Create operating procedures, work instructions, and other documentation for laboratory and pilot equipment
Monitor trends in pharmaceutical technology, chemistry, and pharmacology to propose new projects and ideas
Ensure quality of performed activities, schedule compliance, and adherence to the quality system and regulations
Supervise and coordinate galenic development associates
Participate in colleague education, write scientific and professional papers, and prepare patent applications
Engage in professional seminars and congresses
Participate in local and global evaluation teams for new projects
Act as backup for the manager of galenic development
Independent Expert Associate and Deputy Team Leader, Tableting and Film Coating Department, Solid Dosage Forms
Hemofarm AD (STADA group)
Solve technological problems in production based on tasks from the production manager
Develop and improve production quality, quantity, and productivity
Organize and implement the validation process
Propose new technological procedures, equipment, and work organization in production
Participate in validation of production segments and equipment and in transfer of new products
Write operational procedures and work instructions
Propose measures to address non-compliant product batches
Enforce prescribed work discipline in accordance with corporate regulations and SOP
Ensure timely and high-quality performance of tasks
Implement measures and procedures to achieve specified yields for each production stage
Improve and implement good production practice elements
Enforce safety and health measures at work
Senior Expert Associate and Deputy Team Leader, Tableting and Film Coating Department, Solid Dosage Forms
Hemofarm AD (STADA group)
- Solve technological problems in production as assigned by superiors
- Develop and improve production processes and product quality and quantity
- Organize and implement validation processes
- Stay updated on global trends in pharmaceutical production
- Understand and operate information systems per SOP requirements
- Participate in validation of production segments, equipment, and new product transfers
- Ensure correct application of technology and create operating procedures and work instructions
- Enforce work discipline, good manufacturing practice, and safety measures
- Train employees in the department and prepare reports as requested by superiors
Expert Associate and Deputy Team Leader, Tableting and Film Coating Department, Solid Dosage Forms
Hemofarm AD (STADA group)
- Solve production technological problems as assigned by the head of production and plant manager
- Participate in transfer of new products and validation of production segments and equipment
- Ensure correct application of technology and control individual production stages
- Monitor and optimize raw material consumption
- Propose improvements to existing production
- Operate information systems per SOP requirements
- Implement good manufacturing practice, safety, fire protection, and anti-explosive measures
- Create and implement operational procedures and work instructions
- Train department employees
Process Engineer
SR Dineflon
Organize production and manage workers
Identify new production opportunities
Solve production problems and ensure raw material availability
Participate in marketing presentations for potential customers
Ensure timely and high-quality performance of tasks
Optimize use of production-technical and human resources
Implement measures to achieve specified yields for each production stage
Enforce safety and health measures at work
Summary
Motivated and experienced Chemical (Process) Engineer with over 9 years of experience. Proven track record of solving problems, reduce overall costs and configure the best approach for the most seamless and effective production. I’m highly committed, and goal orientated with excellent interpersonal skills, leadership, and people management. My colleagues and partners recognize me as a decision-maker with great ability of creative thinking.
Languages
Education
Faculty of Technology and Metallurgy, University of Belgrade
Dipl. Ing. of Technology · Chemical Engineering · Belgrade, Serbia
Certifications & licenses
Facilitation Body Language
QbD Process Validation
Root Cause Problem Solving
Lean Six Sigma Green Belt
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