CSV Engineer
Adare Pharma Solutions, Italy
Job Description
Are you ready to join a growing, global drug development and manufacturing organization that puts people first? Come to Adare! We work closely with our pharmaceutical industry partners during all phases of drug development and commercial manufacturing with a mission of improving the lives of patients and medicines essential to people all over the world. Each role and every department within Adare offer you a unique, customized experience with a chance to make a real impact, and is critical to our success. With the help of people like you dedicated to our mission, Adare is transforming lives by transforming drug delivery!
Join our mission at Adare!
What can Adare offer you?
- Health Insurance
- Pension Plan
- Benefits
- Performance-based bonus
We are seeking to hire a CSV Engineer to join our Italian Quality team
If any of the below describes you, we would love to meet you!
JOB SUMMARY
The CSV Engineer reports to the Quality Director - Italy, and supports site projects, technical transfers, and ongoing validation maintenance for Italian facilities cGMP corelated. The CSV Engineer will manage the design, authorship, and execution of commissioning, qualification, and validation studies for any of the following major disciplines:
- Facilities, Utilities, and Equipment (FUE) qualification.
- Unit operations automation qualification with PC and PLC-based supervisory control and data acquisition (SCADA) systems.
- Computerized systems validation.
RESPONSIBILITIES AND LEARNING OPPORTUNITIES
- Understand and interpret US, EU, GAMP and other applicable territories GMP's associated with data integrity and CFR 21 Part 11 compliance.
- Prepare all required documents for validation of computerized systems that control production equipment, laboratory equipment, and any business software that is used in a GxP manner (i.e., QMS, LIMS).
- Provide technical expert support to change controls, investigations, deviations, and CAPAs. Individual must work on complex assignments where analysis of situations or data requires an in-depth evaluation of multiple factors or intangible variables.
- Partner with SMEs to ensure efficient development and execution of testing strategies.
- Collaboratively conducts risk and impact assessments.
- Develop standard operating procedures (SOP) and validation assessments.
- Communicate with customers, suppliers, and internal teams on technical issues, project timeline, and validation support.
- Calculate and interpret data for commissioning, qualification, and validation studies.
- Participate in audits and regulatory agency inspections as a representative of the Quality team.
- Keep up to date with advances in the field, especially regulatory requirements.
- Based on current industry practices and guidelines, support development of best demonstrated computer validation practices within the department.
- Demonstrate continuous improvement to increasing job knowledge and proficiency related to validation in the biopharmaceutical industry and technical understanding capability.
- Acts as the Company's representative by showing respect and being an ambassador for the established beliefs and behaviors of the Company.
- Complete assigned tasks in a safe manner and in a constant state of alertness.
- Work in a cooperative manner with managers, supervisors, coworkers, customers, and the public.
- Upholds Company policies, including the Professional Conduct Policy and Prohibition Against Harassment Policy, and the Business Ethics and Conduct Code.
Requirements
- Minimum of a Bachelor's degree in science, engineering or a related field (or equivalent) and 5 years of experience in the field/role and GMP environment.
- Understand and interpret US, EU, GAMP and other applicable territories GMP's associated with data integrity and CFR 21 Part 11 compliance.
- Direct experience with regulated environments (i.e., cGMP, OSHA, EPA, etc.) is required.
- Experience with testing firmware-based and PC-based applications is a plus.
- Excellent interpersonal effectiveness and communication skills (written and oral).
- Extensive cross-functional team experience.
- Proficient in general computer applications such as, MS Word, Excel, Outlook, etc. and other applicable applications as required.
- Fluency in Italian (main language) and English (both spoken and written) is required.
Benefits
- Health Insurance
- Pension Plan
- Benefits
- Performance-based bonus