Principal Validation Engineer

Location: 

CA-Emeryville, US

Contract Type:  Regular Full-Time
Area:  Manufacturing
Req Id:  483681

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 Validation Engineer is responsible for the execution and management of validation activities for process, cleaning, equipment, computer software or facilities on site. The engineer prepares and executes validation/qualification and re-qualification activities as necessary for new and modified process, cleaning, equipment, computer software or facilities so that the qualification status of site is maintained at all times. The engineer also assists external qualification personnel with the execution of major project qualification activities which require the use of temporary external resources.                                                                                                                                                         

                                                           

 Primary responsibilities for role:

Ensure all company and Site Validation policies and procedures are adhered to.     

Ensure all work carried out and equipment installed is safe, effective and in compliance with the appropriate industry standards.                                                     

Ensure all work undertaken is reflected accurately in up to date Validation / project information files.

Lead/support the development of process, cleaning, equipment, computer software or facilities protocols and ensures they are in line with Validation policies and guidance documents (Liaising with equipment manufacturers, internal and external project personnel to ensure successful qualification execution).                                                     

Seek and retain approval for qualification protocols from site                                                            

User groups (who approve documents from a user group operations perspective)    

Quality (who approve documents from a regulatory compliance standpoint)                  

Lead the execution of qualification protocols on process, cleaning, equipment, computer software or facilities as necessary.                                                         

Ensure the maintenance of a qualification document listing for all qualified equipment on site.

Ensure all qualification documentation is maintained up to date at all times.              

Provide expert guidance for the resolution of technical issues arising during the execution of qualification activities.                                                 

Perform any other activities as directed by the Validation Manager.                                                                                       

                                                           

 

Knowledge, Skills, and Abilities:

• Direct experience with regulated environments (i.e. cGMP, OSHA, EPA) required.

• Technical expertise in biotech unit operations, ability to handle multiple projects at one time.

• Design experience or owners experience in manufacturing processes required.

• Design experience or owners experience in utility systems including purified water, WFI, CIP, SIP, compressed air and waste treatment desired.

• Working knowledge of processes in fermentation, purification and/or formulation required.

• Strong leadership, organizational planning, and project management skills

• Excellent interpersonal effectiveness and communication skills (written and oral)

• Ability to work with a cross functional team to achieve expected results

• Proficient in MS Word, Excel, and Project

• Physical Requirements-Ability to lift 20-30 lbs and stand for an extended period of time.

 

                                                                                                                                                           

Education:

Bachelor’s in Mechanical or Chemical Engineering, Science, or related field.                                                   

Experience:

• 10- 15 years related experience in pharmaceutical/biotech operations.

• Minimum 7 years’ direct/ hands on experience with validation of process, cleaning, equipment, computer software or facilities with thorough working                                                                                                                                                       

 

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:

  • May occasionally lift, carry, push, pull or otherwise manipulate objects up to 25 pounds in weight, and/or lift, carry, push, pull or otherwise manipulate objects up to 10 pounds in weight frequently or continuously.

 

 

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.

Location: NORTH AMERICA : USA : CA-Emeryville:USEMV - Emeryville CA-Headquarters 

 

Learn more about Grifols