Process Engineer
1 week ago
Veranova is a global leader in the development and manufacturing of complex active pharmaceutical ingredients (APIs) for pharma and biotech customers. With deep technical expertise and impressive flexibility, we develop solutions and processes that support and accelerate innovation.
Job Description
The Process Engineer is responsible for the design and implementation of elements of new or improved processes as they are transferred from development to production.
Key Responsibilities / Accountabilities
- Collaborate with cross functional teams to develop safe, efficient, practical and commercially viable processes to generate a consistent quality API supply fit for its intended use, with essential considerations given to optimizing process yields, turnaround times, and productivity.
- Lead process improvements efforts which improve yields and/or lower production costs, enhancing the overall efficiency and cost effectiveness of the Pharmaceutical Materials production processes.
- Design and conduct a variety of experiments or plant trials to define process conditions that match or improve plant capabilities to run commercial processes.
- Contribute in pilot and validation runs in the manufacturing plant
- Collaborate with Project/Facilities Engineering in capital projects during front-end design (URSs, PFDs, M&E Balances), PHAs, design reviews, commissioning, start-up and operator training
- Lead troubleshooting efforts related to processing and process equipment problems while gathering relevant information and compiling necessary reports.
- Write and review Batch Records, SOPs, Process Validation Protocols, and other technical reports
- Collaborate with the EHS group on environmental, health and safety related aspects of new processes and process modifications; performs related emission calculations
- Develop process performance tracking procedures and analyses existing data for optimization potential
- B.S. in Chemical Engineering or equivalent technical degree required.
- Minimum of 3 years manufacturing or process engineering experience in Pharmaceuticals required.
- Advanced knowledge of Microsoft Office Products (Word, Excel and PowerPoint) required.
- Knowledge of commonly used equipment, technical concepts and procedures within bulk API batch manufacturing.
- Team oriented and able to work efficiently in a project driven environment.
- Strong verbal and written communication and presentation skills.
- Excellent organization skills and ability to prioritize and multi-task.
- Knowledge of FDA/cGMP guidelines and practices.
- Strong statistical analysis skillset.
- Strong Failure Mode and Effect and Root Cause analysis skills.
Additional Information
All your information will be kept confidential according to EEO guidelines.
Veranova is an Equal Opportunity Employer. It is the policy of Veranova to provide equal employment access and opportunity to all persons regardless of age, race, color, national origin, religion, sex, sexual orientation, gender identity and/or expression, physical or mental disability, genetic information, citizenship, marital status, veteran status, or any other characteristic protected by federal, state, or local law.
All applications are carefully considered, and your details will be stored on our secure Application Management System. This is used throughout Veranova for the selection of suitable candidates for our vacancies as they arise. Veranova respects your privacy and is committed to protecting your personal information. For more information about how your personal data is used please view our privacy notice.
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