LL01-062724 - Process Owner - Validation & Engineering Group

Validation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:

• Process Owner

Qualifications:

• Bachelor's Degree in Science or Engineering.
• Minimum of 5 years of experience in direct pharmaceutical, medical device or biotechnology industries.
• Experience in direct process / manufacturing areas.
• Must be proficient using MS Windows and Microsoft Office applications.
• Strong knowledge in cGxP and regulatory guidance as well as understanding of how they are applied to regulatory compliance.
• Available to work extended hours, possibility of weekends and holidays.

Responsibilities

The expected main responsibilities and accountabilities are:

1. Demonstrated ability to understand what is critical about the process.
2. Recognizes what are the critical quality attributes and process parameters.
3. Understands what the output is important to internal customers of the process.
4. Ability to identify what the process is tied to the regulatory filings.
5. Monitors process performance with data by including both input/process parameters and output measures.
6. Monitor data compiled by process operators and summarize into a dashboard.
7. Ensures the process is documented, and that the documentation is used and updated routinely.
8. Championing efforts to identify the best-demonstrated process methods, particularly what parts of the process must be standardized so that output quality and reliable supply to patients do not suffer.
9. Documenting the best-demonstrated methods and ensures they are referenced constantly.
10. Updates the documentation for the process when it changes.
11. Owns the SOP and batch records for process operation.
12. Closely collaborates with internal and global functions (Manufacturing, Quality, and Facilities & Engineering) to ensure a control plan is in place.
13. Ensures everyone in the work area knows how the process should operate.
14. Assurances everyone knows how to detect signs of trouble and what to do if a problem appears (response plan). Confirms process data is charted and posted in the work area.
15. Ensures that any improvements identified through projects are incorporated and maintained in the process.
16. Act as Process SME during internal and/or external Regulatory inspections.
17. Provides necessary training and resources for the process operators to do their jobs well and keep getting better. Resources may include appropriate training, materials, information, and equipment.
18. Foster a culture of continuous improvement through employee selection, training and mentoring while focusing on operational efficiency and the elimination of “non-value added” activities.
19. Provide a positive and equitable working environment emphasizing the CSL Values: Customer Focus, Innovation, Integrity, Collaboration, and Superior Performance.
20. Complies with requirements from CSL Behring’s Safety Program, including Health and Safety mandates and OSHA requirements.
21. Completes any other duties/responsibilities assigned by senior management.