What are the responsibilities and job description for the Owner position at Validation & Engineering Group, Inc?
Department : Field - LL Location : Kankakee, IL
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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 :
- Demonstrated ability to understand what is critical about the process.
- Recognizes what are the critical quality attributes and process parameters.
- Understands what the output is important to internal customers of the process.
- Ability to identify what the process is tied to the regulatory filings.
- Monitors process performance with data by including both input / process parameters and output measures.
- Monitor data compiled by process operators and summarize into a dashboard.
- Ensures the process is documented, and that the documentation is used and updated routinely.
- 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.
- Updates the documentation for the process when it changes.
- Owns the SOP and batch records for process operation.
- Closely collaborates with internal and global functions (Manufacturing, Quality, and Facilities & Engineering) to ensure a control plan is in place.
- Ensures everyone in the work area knows how the process should operate.
- 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.
- Ensures that any improvements identified through projects are incorporated and maintained in the process.
- Act as Process SME during internal and / or external Regulatory inspections.
- 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.
- 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.
- Provide a positive and equitable working environment emphasizing the CSL Values : Customer Focus, Innovation, Integrity, Collaboration, and Superior Performance.
- Complies with requirements from CSL Behring’s Safety Program, including Health and Safety mandates and OSHA requirements.
- Completes any other duties / responsibilities assigned by senior management.
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Last updated : 2024-11-15
