Commissioning & Qualification (C&Q) Center of Excellence (CoE) Subject Matter Expert (SME)SchweizR-1955181095 CSL Behring AG (CH)
The Commissioning & Qualification Center of Excellence (CoE) Subject Matter Expert (SME) role leads the organization in the development and implementation of engineering procedures, standards and templates library to ensure reliability and compliance with company policies and government regulatory requirements for facilities, utilities, equipment, analytical equipment and computerized manufacturing systems through the definition, planning, and execution of Commissioning & Qualification activities in projects and routine manufacturing operations.
The C&Q CoE SME takes a proactive role in supporting projects and providing support by building a high level of trust with internal and external stakeholders.
Reporting Relationships: List other positions in the company that are reporting into this position.
- Understanding with proficient knowledge of common unit operations and processes used in biopharma /pharmaceutical manufacturing.
- Preparation and execution of CQV life cycle deliverables, project plans,
- URS/DQ/RTM/Risk Assessments/commissioning test plans/IOQ/PQ/Final reports, as needed.
- Collaborate with the Computerized System Validation team for the delivery of integrated
- testing for manufacturing computerized systems. Working knowledge of process automation and computer system validation concepts, GAMP methodologies, 21 CFR Part 11 compliance and latest industry expectations for data integrity.
- Provide Peer Review for key project designs.
- Coordinate external contracted project resources and third parties/vendors for the flawless execution of Commissioning and Qualification projects activities, as needed.
- Review of CQV deliverables generated by project team members.
- Effectively interfacing and communicating with 3rd parties, client and CQV project teams.
- Review the technical content in the C&Q sections of regulatory dossiers.
- Support Sites with Internal and External cGxP Audit Findings. Act as Point of Contact
- (POC) for program-specific regulatory inspection.
- Maintains global expertise through ongoing training and participation in industry forums.
- Assist the C&Q Strategy Lead in the delivery and project management processes required to complete projects within timeline and budget.
- Integrate CQV into the project lifecycle, working with other disciplines, both internal and
- BS degree in engineering, life sciences or other related technical field, combined
with 5 years (or MS plus 2 years) working experience in commissioning and
qualification in a regulated industry (i.e., GxP manufacturing / research and
development) with a broad-based understanding of pharmaceutical manufacturing
and overall business processes.
- Good communication and conflict management skills to influence technical
experts and stakeholders at all levels in the organization.
- Significant commissioning and qualification experience in Pharmaceutical /
- Advanced knowledge of pharmaceutical, manufacturing and laboratory systems
- Working understanding of lean processes principles.
- Comprehension of Industry and Regulatory Authorities Regulations related to
- Biopharmaceutical Facilities including FDA, EMA, ICH, ASTM, ISPE, TGA,
- Excellent planning, organizing, analysis and problem-solving skills. Strong
background and understanding in the planning and execution of projects.
- Demonstrated business acumen, understanding of business needs, risks and
regulatory implications in the development/assessment of design alternatives
- Ability to work in a fast-paced environment, organized and able to prioritize
tasks to meet multiple deadlines.
- Ability to use discretion with sensitive/confidential information.
- Demonstrated proficiency with standard Project Management tools (MS
- Project, Excel, Visio, SharePoint, PowerPoint) and templates.
- Excellent interpersonal, verbal and written communication skills.
- Excellent interpersonal skills with experience dealing with a diverse workforce.
- Experience in Heating ventilation and air condition (HVAC) a strong asset.
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About CSL Behring
CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring.
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