Chicago, IL, USA
Up to $95,000 per year plus benefits
9 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 several senior validation engineers (with a strong background in equipment and process) to join them and build the future! This role will involve planning, communicating and leading scientifically sound, risk-based strategies for large scale, multi-facetted validation projects in a cGMP environment. Working closely with other validation department personnel as well as cross-functionally with Manufacturing, Engineering, Critical Utilities, Quality Assurance, and R&D to achieve project deliverables. Independently designing, scheduling, and executing qualification/validation experiments which demonstrate compliance with regulatory requirements, product license restrictions, and industry standards. Preparing detailed concise reports on completed studies that summarize test results and their conformance to the protocol acceptance criteria. Representing the validation department on cross-functional and/or global project teams.
Summary of Responsibilities:
1. Responsible for testing the systems (equipment, utilities, facilities, and processes) used to develop or manufacture products in a cGMP environment.
2. Plans, communicates and leads scientifically sound validation strategies for small to large scale multi-facetted validation projects including timelines, cost estimates, and assigned resources (validation contractors).
3. Leads assigned resources (validation contractors) to achieve project deliverables, as required.
4. Effectively schedules and communicates with appropriate functional groups (i.e. Manufacturing, Engineering, and QC Labs, etc.) regarding validation study execution/testing requirements and status of assigned execution activities.
5. 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 root cause of validation study discrepancies
6. Prepares detailed, concise reports on completed studies that summarize the test results and their conformance to defined acceptance criteria.
7 Able to recognize and trouble shoots problems associated with validation studies, equipment, and procedures.
8. Assists in the preparation of proposals and bid packages to secure validation contractor services.
9. May serve as Subject Matter Expert (SME) for review of Validation and Engineering Qualification protocols and reports for adherence to cGMPs, good documentation practices, and general quality oversight.
10. Assists in review of Deviations, Change Controls, Material Change Controls, Document Change Controls as an SME for Validation.
11. Provides technical support/training to Validation department personnel and other functional groups (i.e. Manufacturing, Engineering, and QC Labs, etc.) as needed.
12 Researches governmental regulatory requirements and industry guidance on assigned projects.
13. Assists the in development of validation programs and SOPs to meet current industry standards, site Quality, and external Regulatory requirements.
14. Supports the facility in internal and external inspections.
15. 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.
16. Provide a positive and equitable working environment emphasizing: Focus, Innovation, Integrity, Collaboration, and Superior Performance.
17. Complies with requirements from the Safety Program, including Health and Safety mandates and OSHA requirements.
18. Completes any other duties/responsibilities assigned by senior management.
- BS in Engineering, Physical or Biological Science with 5+ years validation experience or Associates Degree with 8+ years related validation experience. Proven demonstration to perform in the role may also be considered.
- Experience with current US and international regulations, industry guidance and best-practices for the qualification/validation of facilities, utilities, equipment and process support commercial manufacturing
- Experience in project management, problem solving analytical/conceptual thinking and time management.
- Developing skills in interpersonal communication, delegation, and decision making
- Direct interaction with FDA desirable
You can apply for this role by sending us your CV or by calling us now!
Specialist Validation & C&Q Recruiter
Contact: +44 203 675 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/.