Manager Validation
Round Lake, IL
Req ID 51523BR
Business Title
Manager, Validation
Business
Global Quality
Sub-Business
Medical Products Support
Country
US
State/Province
Illinois
Location of Position
Round Lake, IL
Shift_
1st
Job Description
This position is in the Quality Management organization and is responsible for multiple segments of the validation function at the Round Lake Drug Delivery aseptic pharmaceutical manufacturing facility.
Responsibilities include:
- Managing, developing and implementing validation processes to ensure that products meet with appropriate regulatory agency validation requirements, internal company standards and current industry practices.
- Providing technical direction to the Quality Engineering staff and driving successful completion of validation projects within boundaries of project scope and budget.
- Responsible for the overall management of the customer complaint process from complaint receipt through resolution and complaint trending. Proactively and regularly communicate with Round Lake Drug Delivery plant staff to update on validation and customer complaint status.
- Manage, identify, hire, develop and recognize technical staff, which will include senior level engineers and technicians. May manage up to 8 direct reports.
- Responsible for policy setting and defining procedures for the staff in accomplishing and documenting validation projects.
- Plan and manage validation projects in the areas of equipment, software, process, control system and critical system validation and be able to manage a variety of complex issues in associated validation projects, plans and schedules.
- Responsible for approving scope of work for the validation team. Review and approve validation protocols and reports and support the overall change control documentation process as a ""technical approver.""
- Oversight for the development and completion of Validation Master Plans, Design Qualification, Installation Qualification, Operational Qualification, Performance Qualification and Validation Maintenance packages and complaint handling procedures.
- Directing or participating in performing technical failure mode analysis of processes/product, statistical analysis and design of experimental approaches, developing statistical process control programs and reporting on trends to reduce product/process variability.
- Develop and administer budget for the Quality Engineering staff.
Job Requirements
Must be well versed in engineering or related disciplines. Must have knowledge of GMPs, FDA guidelines, process validation and customer complaint handling.
Must have demonstrated effective supervisory skills.
Must be able to communicate effectively at all levels in verbal and written form, including technical/business writing. Will be expected to interface with regulatory agencies with respect to validation and customer complaints.
Must be self-motivated, have good interpersonal skills, capable of analyzing and solving complex problems through innovation and experience.
Proficient in Microsoft Word, Excel, and other related statistically based computer software applications.
Sound industry knowledge, project proficiency, and autonomy expected.
Requires excellent analytical skills with systematic approaches to problem solving. May be considered a Subject Matter Expert (SME) in various disciplines.
Must not be allergic to Penicillins or Cephalosporins.
Minimum of a BA or BS preferably in the Life Sciences/Engineering/Chemistry or other job-related discipline required.
Minimum of 7 years related experience in validation required within a pharmaceutical, biotech or related industry.
Project Management and Supervisory experience required.
Doing Work that Matters
Baxter provides its employees with comprehensive compensation and benefits. To view additional opportunities at Baxter and to learn more about the company, please visit our Web site at company website. EOE M/F/D/V.
