Senior CSV Automation Engineer

Are you ready to join a world leader in the exciting and dynamic fields of the Pharmaceutical and Medical Device industries? PQE Group has been at the forefront of these industries since 1998, with 40 subsidiaries and more than 2000 employees in Europe, Asia and the Americas.

Due to our constant growth, we are looking for a full-time CSV Automation Engineer with 5 years of experience within the Lifescience/Biotech industry fitting the following mandatory skill-set and willing to work in Indianapolis, Indiana.

Responsibilities:

• Revise and manage approval process for User Requirement Specifications (URS) and Technical Quality Planning and Specification (TQPAS) documents
• Create, review, and support approval of various validation documents, including: Configuration Specification (SCADA-specific); Functionality Specification (SCADA-specific); Hardware Design Specification (Controls only); Software Design Specification; Functional Risk Assessment (FMEA); Data Archival Plan and Reports; Traceability Matrix; Audit Trail Review Analysis (ATRA)
• Develop system-related SOPs, including: System Administration SOP; Automation Handbook (site-wide or equipment-specific); User and Security Management; Backup and Restore Procedures; Disaster Recovery Management; End-user Operational SOPs
• Conduct Sensor Risk Assessments and Design Qualification
• Create and execute wrapper Installation Qualification/Operational Qualification (IOQ) for Quality environment, leveraging Site Acceptance Test (SAT) and Site Test Specification (STS) protocols
• Provide support for deviations and Corrective and Preventive Actions (CAPAs)
• Generate comprehensive Summary Reports
• Execute approved protocols, including generating and closing all protocol deficiencies, in coordination with vendor SAT and STS documentation

Requirements:

• Bachelor's degree in Computer Science, Engineering, or related field
• Minimum 5 years of experience in Computer System Validation within the pharmaceutical or radiopharmaceutical industry
• In-depth knowledge of GMP regulations, 21 CFR Part 11, and GAMP 5 guidelines
• Experience with SCADA systems, manufacturing execution systems, and laboratory information management systems
• Strong understanding of risk-based validation approaches
• Must be able to work onsite at the manufacturing facility
• Willingness to complete GMP curricula training to support CQV activities
• Proficiency in using validation tools and software (e.g., Kneat Paperless Validation system)
• Strong analytical and problem-solving skills
• Excellent communication and interpersonal skills
• Excellent documentation and technical writing skills
• Ability to work independently and collaboratively in a cross-functional team environment
• Fluent in English
• Have valid visa to work in US

Preferred Qualifications:

• Experience in radiopharmaceutical manufacturing or related fields
• Familiarity with hot cell containment systems and associated control system
• Knowledge of FDA and EMA regulations specific to radiopharmaceuticals

Next Steps

Upon receiving your application, if a match is found, the Recruiting department will contact you for an initial HR interview. If there's a positive match, a technical interview with the Hiring Manager will be arranged. In the case of a positive feedback coming from the Hiring Manager interview, the recruiter will contact you for the next steps or to discuss our proposal. Alternatively, if the feedback is negative, we will contact you to halt the recruitment process.

Working at PQE Group

As a member of the PQE team, you will be part of a challenging, multicultural company that values collaboration and innovation. PQE Group gives you the opportunity to work on international projects, improve your skills and interact with colleagues from all corners of the world. If you are looking for a rewarding and exciting career, PQE Group is the perfect place for you. Apply now and take the first step towards an amazing future with us.