CA-San Diego, US
Contract Type: Regular Full-Time
Req Id: 75606
For more than 75 years, Grifols has worked to improve the health and well-being of people around the world. We are a global healthcare company that produces essential plasma-derived medicines for patients and provides hospitals and healthcare professionals with the tools, information and services they need to deliver expert medical care.
Headquartered in Barcelona, Spain, Grifols has over 20.000 employees in 30 countries. Grifols' three main divisions - Bioscience, Diagnostic and Hospital - develop, manufacture and market innovative products and services available in more than 100 countries.
A leader in transfusion medicine, the Diagnostic Division is a global business focused on providing innovative solutions to help ensure the safety of the blood and plasma supply, detect human diseases and monitor therapies. The division advances patient care with diagnostic solutions to improve disease detection and management, and simplify laboratory operations.
This person is responsible for managing a validation program to support Grifols Diagnostic Solutions products. This role includes defining and prioritizing validation activities and resources to meet organizational objectives, ensuring that the validation program complies with all Grifols requirements and industry standards, and partnering with Manufacturing, Manufacturing Sciences, QA, QC, and Engineering. The person is also responsible for setting department objectives, expectations for the staff, and developing individual and team performance.
Primary responsibilities for role:
Direct the validation activities to support GMP manufacturing in accordance with appropriate regulatory requirements, cGMPs, corporate policies and procedures.
Establish strategic goals and objectives, including prioritization, coordination, and completion, of GMP validation projects.
Evaluate and review/approve validation packages to ensure they meet the current FDA guidance and Grifols guidelines.
Participate on the Validation management team and act as Validation subject matter expert in cross functional meetings.
Ensure the validation program adequately defines revalidation and/or requalification requirements based on risk management and accordingly manage the validation maintenance program.
Lead the development of master validation plans, SOPs, risk assessments and validation protocols for new facility/equipment, process/equipment modifications, technical transfer, and periodic revalidation.
Provide validation assessments and evaluations for change controls, deviations, and CAPAs.
Provide guidance regarding validation strategy, programs and policies.
Support corrective actions including investigating and resolving deviations as related to equipment and cleaning/process validation.
Ensure appropriate acceptance criteria are applied and justified.
Work closely with Manufacturing, Manufacturing Sciences, Engineering, QC, and QA.
Describe and defend validation program during audits and regulatory inspections.
Provide leadership for the group and work with validation staff to assist in the training of personnel as well as evaluate the effectiveness of training.
Manage and develop staff by setting individual/group goals and manage performance based on Grifols guidelines
May require travel up to 10% to vendors or other Grifols sites as needed to support commissioning and factory acceptance testing of new equipment.
Minimum BS in Chemical or Mechanical Engineering, Science, or related field.
10+ years' experience in pharmaceutical/biotech operations, with working knowledge of diagnostics reagent production unit operations, cGMPs, FDA regulatory guidelines and validation best practices.
Expertise in the following areas are required: Cleaning Validation, Equipment Qualification, Facility/Utilities Qualification, and Process Validation.
Proficient in both domestic and international GMP regulations and industry guidance documents (eg CFRs, ICH, ISPE, ASTM, etc), and capable of providing guidance to incorporate continuous improvements into validation activities and procedures/policies.
Strong understanding of risk-and science-based approach to validation is desired.
Experience with process risk assessments including FMEAs.
Project Management experience is a plus.
Must demonstrate the ability to think critically and analytically with hands on experience in equipment/process trouble-shooting and problem solving.
Excellent interpersonal effectiveness and communication skills (written and oral) required to work across departments and management levels. Ability to function effectively and independently in a fast-paced, dynamic environment
Ability to review and interpret engineering and facility drawings.
Strong team player aligned with Grifols Corporate Values
5- 8 years of management experience with strong leadership, organizational planning, project management skills, in addition to strong technical background required to coordinate multi-disciplinary teams.
Grifols is committed to Equal Employment Opportunity (EEO) and to compliance with all Federal, State and local laws that prohibit employment discrimination on the basis of race, color, age, national origin, ethnicity, religion, gender, gender identity, pregnancy, marital status, sexual orientation, citizenship, genetic disposition or characteristics, disability or veteran's status or any other classification protected by applicable State/Federal laws.
Location: NORTH AMERICA : USA : CA-San Diego:USSDW - San Diego CA - Willow Ct Mfg
Learn more about Grifols