Process Engineer II MS&T

Location: 

CA-Emeryville, US

Contract Type:  Regular Full-Time
Area:  Manufacturing
Req Id:  484044

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.

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Process Engineering II MS&T for protein production and protein purification

 

Summary:

The Process Engineer II is part of a Process Engineering Team in Emeryville which improves the maturity, scale, and efficiency of manufacturing processes; drives key initiatives that includes capacity expansion, process scale-up activities, site transfers, and critical pieces of new product introductions. This position will be working in Fermentation, Purification, Bulk Fill and Technical Services with focus on our commercial manufacturing. The position reports directly to the Manager of Manufacturing Support. Project leading and work experience in a regulated (GLP/cGMP) industry is required to be able to fulfill the role as well as a strong manufacturing and biotech background. The Engineer II will work with Scientists and Specialists within MS&T, is partnering cross-functionally with R&D, Quality, Production, and other engineering groups.

 

Why Grifols:

Our sustainable growth allows this role to work in a startup-like environment, but with the stability of a multinational, global acting company. The Process Engineer is a decision maker, creator and a project leader and is given the opportunity to grow with us. The work environment is characterized by an open leadership style and an open and supportive culture.

 

Your primary responsibilities:

  • You initiate and lead process equipment improvements within the following Manufacturing areas: Fermentation, Purification, Bulk Fill or Technical Services
  • You support the commercial manufacturing group for routine manufacturing processes. That means you: support all QA Compliance investigations for process deviations, technical assessment of issues, root cause investigations, CAPA task management. You own and drive change control records for the department. You prepare equipment related operating procedures and/or relevant engineering documents (SOPs, protocols & reports for FATs, comparability, manufacturing process validation testing), you also interpretate data and communicate technical results in cross-functional settings.
  • You also participate in process improvement, development, scale up and qualification activities
  • You provide guidance to staff with production support activities, including pre-production checks and equipment testing activities
  • You execute system/equipment-based studies to screen, optimize, and scale production processes, you analyze and interpret results,
  • You provide technical support for new products, including process/equipment feasibility assessments, process, and equipment requirements
  • You evaluate new technology and support implementation of new process equipment into GMP manufacturing. 
  • You support process technology transfers from other depts. to increase the effectiveness of Manufacturing processes
  • You partner and collaborate with the site Project Management Organization with higher level long-term initiatives
  • You provide support to ensure successful manufacturing process comparability and process validation runs by assessing risk, setting
  • You participate in projects associated with process equipment, process improvements, as well as design, start-up, commissioning, and qualification of new investments

 

More about us, benefits we provide you:

  • salary in line with the market as well as an annual bonus target
  • free parking
  • flexible working hours, 20% remote
  • paid Vacation
  • Professional development opportunities (training, career development)
  • Gym pass, 15, 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 benefits

 

About you:

Knowledge, Skills, and Abilities:

  • Technical expertise in biotech unit operations and equipment, especially in the area of protein production and protein purification
  • Experience with automated equipment engineering and validation
  • Working knowledge and experience in cGMP environments (understanding of equipment, technology, and quality systems requirements) is required
  • Experience with start-up, commissioning, and validation, leading and supporting factory acceptance tests and site acceptance as well as project design and construction a plus
  • Experience supporting FDA and other Regulatory inspections a plus
  • Excellent communication skills, organizational skills, writing and problem-solving skills
  • Ability to work independently, manage multiple priorities, with the ability to prioritize and complete activities on time
  • Must be self-motivated, detail-oriented, collaborative, and able to work effectively in a fast-paced environment.

Education:

  • Bachelor in Biochemical, Chemical or Mechanical Engineering, or a Master
  • 5+ years’ experience in a pharmaceutical / biotech / vaccine operations and validation principles, with thorough working knowledge of production unit operations or 3+ years if you have a Master’s degree

 

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.

 

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.

 

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

 

Learn more about Grifols