Chicago, IL, USA
5 months ago
We are currently working with a very large pharmaceutical client based in Chicago, listed as one of the top 50 employers in the world by Forbes magazine. This company are in the middle of an exceedingly exciting growth phase and are investing $2.5 billion in this site alone.
They are looking for an equipment engineer to join them in building the future!
- Responsible for testing the systems (equipment, utilities, facilities, and processes) used to develop or manufacture products in a cGMP environment.
- Plans communicate and lead scientifically sound, risk-based validation strategies for small to medium scale validation projects. May assist in large scale projects as required.
- Prepares validation project plans, protocols, and test equipment for execution. Collects and evaluates validation test data for conformance to protocol acceptance criteria and/or to investigate and determine the root cause of validation study discrepancies
- Prepares detailed, concise reports on completed studies that summarize the test results and their conformance to defined acceptance criteria.
- Effectively communicates with appropriate functional groups (i.e. Manufacturing, Engineering, and QC Labs, etc.) in regards to the needs and status of assigned study execution activities
- Recognizes and troubleshoots problems associated with validation studies, equipment, and procedures.
- May serve as Subject Matter Expert (SME), reviewer, or approver of controlled documents within the area(s) in of competency
- Researches governmental regulatory requirements and industry guidance on assigned projects
- Assists the department in developing programs and SOPs to meet current industry standards, site Quality, and external Regulatory requirements.
- Provides technical support/training to Validation department personnel in areas of competency. Provides technical support other functional groups (i.e. Manufacturing, Engineering, and QC Labs, etc.) as needed.
- Supports the facility in internal and external inspections.
- Other tasks as required by Departmental Management.
- 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.
- BS in Engineering, Physical or Biological Science with 3+ years validation related experience or Associates Degree with 6+ year’s specific validation experience. Proven demonstration to perform in the role may also be considered.
- Experience with the current US and international regulations, industry guidance and best practices for the qualification/validation of facilities, utilities, equipment, and process support commercial manufacturing
You can apply for this role by sending us your CV or by calling us now!
Contact: 0203 675 2956 or email firstname.lastname@example.org.
We recruit for a variety of opportunities in Life Sciences so feel free to get in touch with us to find out how we can help you.
You can learn more about me by looking me up on LinkedIn. Search for Ellen Hickey https://www.linkedin.com/in/ellen-hickey-609a33b7/.