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Grifols Shared Services North America, Inc Senior Validation Engineer in San Diego, California

Do you want to join an international team working to improve the future of healthcare? Do you want to improve the lives of millions of people? Grifols is a global healthcare company which, since its foundation in Barcelona in 1909, has been working to improve the health and well-being of people all over the world. Our four divisions - Bioscience, Diagnostic, Hospital and Bio Supplies - develop, produce and market innovative medicines, solutions and services in more than 100 countries and regions.

Summary :

The Senior Validation Engineer is responsible for the execution and management of validation activities for qualification/validation of Facilities (e.g., HVAC Systems, Building Monitoring Systems, Freezers/Cold Rooms, etc.), Utilities, Cleaning Processes, Equipment IOPQ’s, and Process Performance Qualifications (PPQ’s). Provide validation expertise in support of risk assessments and pFMEA’s. Provide validation review and approval for all SOP’s, DMR’s, Change Controls, etc., that require Validation review/approval. The SVE prepares and executes validation/qualification and re-qualification activities as necessary for new Facilities, Utilities and modified equipment, cleaning processes and PPQ’s so that the qualification status of site is maintained. The SVE also assists external qualification personnel with the execution of major project qualification activities which require the use of temporary external resources.

Why Grifols:

Our sustainable growth strategy allows this role to work in a startup-like environment, but with the stability of a multinational, global acting company. The Senior Validation Engineer will create and Validate protocols for our Immunohematology Lab and product line with us and is given the opportunity for growth within our organization. The work environment is characterized by an open leadership style and an open and supportive culture.

Your primary responsibilities :

  • Research and develop qualification and validation protocols, execution of the studies, analysis of the resulting data and development of the final report.

  • Ensure all qualification/validation work carried out on Facilities, Utilities, Equipment and Processes installed/qualified are safe, effective and in compliance with company and industry standards

  • Evaluates and analyzes data. Develops and presents recommendations based on the data analysis.

  • Write and execute IOPQ protocols and reports for computerized equipment and systems to ensure 21 CFR Part 11 compliance on all aspects of equipment/systems.

  • Completes qualification activities / validation project timelines and communicates project updates to cross functional teams.

  • Write and/or support development of MVP’s and MVR’s (Master Validation Plans and Reports) for new processes introduced into Manufacturing

  • Investigates and documents all validation related deviations / failures including determination of assignable cause. Determines impact of failures on validation study.

  • Complete final written reports which analyze and summarize results.

  • Participates in departmental meetings and cross functional team meetings as required. Leads/Facilitates team meetings as required.

  • Applies acquired validation experience to develop, enrich and streamline current validation practices.

  • Evaluates and communicates the status of current validation projects to validation management.

More about us, benefits we provide you

  • Salary in line with the market as well as an annual bonus target

  • Flexible working hours, 80% on site and 20% remote

  • Free parking

  • Professional development opportunities (training, career development)

  • Gym pass, Employees perks program

  • 401 (K) Retirement Plan (Grifols will match 100% on the first 4% of eligible compensation you contribute, and 50% on the next 2% of eligible compensation you contribute)

  • Health insurance: Medical, Dental, Vision

  • Travel accident insurance, Life and AD and D Insurance

  • Short- & Long-Term Disability Insurance

  • Health Savings Account, Flexible Spending Account

  • Critical Illness, Accident, Hospital Indemnity coverages

  • Adoption Assistance

  • Employee assistance plan

About you:

Knowledge, Skills, and Abilities we are looking for :

  • Excellent technical writing and analytical skills.

  • Technical expertise in qualification/validation of new Facilities, Utilities, Modified Manufacturing Equipment and Manufacturing processes with the ability to handle multiple projects at one time. Experience in a Biologics, Medical Device or FDA related manufacturing facility.

  • Ability to write and execute IOPQ protocols and reports for Facilities, Utilities, Modified Manufacturing Equipment, and processes.

  • Ability to write and execute IOPQ protocols and reports for computerized systems and equipment to 21 CFR Part 11 compliance.

  • Experience in writing and executing PPQ protocols and reports for manufacturing of new and existing products when required.

  • Familiarity with a cGMPs and industry and federal guidelines required. Proficient in computer applications such as Word, Excel, and Access.

  • Strong interpersonal skills required for interaction with Manufacturing, QA, QC and RA personnel.

  • Knowledge of information systems such as LIMS systems and laboratory systems such as HPLC’s and GC’s.

  • Excellent technical writing and analytical skills.

  • Experience with writing regulatory submission reports and related qualification and validation reports.

Education and Experience we require for this role:

  • Typically requires a BS degree in Computer Science, Engineering, Biology, Chemistry, Physical Science or equivalent. Experience in related Quality Assurance, Quality Control or Engineering function is acceptable. Technical writing skills required for regulatory submission related qualification and validation reports.

  • 5 – 7 years of experience writing and executing IOPQ’s (Installation, Operation, Performance Qualifications) protocols / reports for Qualification/Validation of new Facilities, Utilities, modified manufacturing Bulking/Filling equipment, and Manufacturing processes. Writing and executing Process Performance Qualifications (PPQ’s) and reports.

  • Ability to work with Ellab or Kaye monitoring systems for qualification of temperature-controlled rooms and TCU’s (Temperature Controlled Units) is required.

  • Writing, executing and performing Environmental Monitoring Performance Qualifications (EMPQ’s) is a plus.

  • Working with and qualification of equipment used for Red Blood Cells (RBC’s) processing is a plus.

Equivalency

Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements. Example: If a job level requires a Bachelor’s degree plus 4 years of experience, an equivalency could include 8 years of experience, an Associate’s degree with 6 years of experience, or a Master’s degree with 2 years of experience. .

Occupational Demands

Work is performed in both a lab and an office environment. Frequently sits for 4-6 hours per day. Occasionally walks. Occasionally bends and twists neck. Light to moderate lifting and carrying objects with a maximum lift of 50lbs. Some occasional travel within the United States. Able to communicate complex information and ideas so others will understand; ability to listen and understand instruction. Ability to apply abstract principles to solve complex conceptual issues.

EEO Minorities/ Disability/Veterans

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. We will consider for employment all qualified Applicants, including those with Criminal Histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance.

This job description is intended to present the general content and requirements for the performance of this job. The description is not to be construed as an exhaustive statement of duties, responsibilities, or requirements. Managers and supervisors may assign other duties as needed.

Req ID: 491852

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