LL01-062724 - Process Owner - Validation & Engineering Group : Job Details

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.

* Documenting the best-demonstrated methods and ensures they are referenced constantly.

* 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 Behrings Safety Program, including Health and Safety mandates and OSHA requirements.

* Completes any other duties/responsibilities assigned by senior management.