Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.
Job Summary:
The Manufacturing Specialist (MES) will be responsible for development, configuration and testing of Master Batch Records (MBRs) from initial to final design. The successful candidate will have at least five years' experience in a pharmaceutical or biotech industry and will have demonstrated competency in a team environment to deliver results on time with project and commercial timelines.
Responsible for the development, configuration and testing of Master Batch Records (MBRs) from initial to final design.
Responsible for leading MBR development design reviews including liaising with Operations, Process Validation and Quality functions and external functions such as Engineering, IT, R&D, other Grifols production sites as required.
Responsible for drafting, executing, and reviewing Application Lifecycle Management test scripts and test sets for testing MBR design.
Responsible for the support and ongoing development of the Grifols Biologicals (GB) Operations MES system in development of MBRs and improving the MES business process.
Responsible for training of Electronic Batch Record (EBR) end-users (Supervisors, Operators, Technical/QA/Support staff).
Responsible for the development, review, and update of MES Standard Operating Procedures.
Responsible for the preparation and management of MBR change requests and associated change request forms (and other documentation) in a timely manner by liaising with customers, System Owner, Quality, etc.
Accountable for adherence to established timelines and metrics for the deviation, change control and CAPA process.
Responsible for providing technical support where required and as directed by Operations leadership
Responsible for any applicable equipment integration design, configuration and testing to allow MBR interaction with shop floor equipment - OSI PI, Recipe Managers - Siemens PCS7, Wonderware. Werum, etc.
Responsible for resolving interface errors and stock discrepancies between ERP/MES as required.
Liaison with Grifols MES core-team to troubleshoot and develop new ways of working
Knowledge, Skills and Abilities:
Experience in database configuration and creation
Experience in pharmaceutical manufacturing and GMP
Working knowledge of operations in pharmaceutical/biotech industries or aseptic processing an advantage
Knowledge of regulation requirements (GMP& IT/System Integration, etc)
Experience with Osi Pi software
Experience with electronic batch records in a pharmaceutical environment
Requirements and Education:
Bachelor's degree in Engineering or Science or related industry qualification
Project Management Certification preferred
A minimum of 3+ years' experience in an operation's pharmaceutical environment.
Occupational Demands : Work is performed in an office environment with exposure to electrical office equipment. Frequently sits for 6-8 hours per day. Frequent hand movement of both hands with the ability to make fast, simple, movements of the fingers, hands, and wrists. Occasionally walks and stands. Occasionally bends and twists neck. Light to moderate lifting and carrying objects with a maximum lift of 25lbs. Frequently drives to site locations with occasional travel within the United States. Able to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken and written words and sentences. Interacts with others, relates sensitive information to diverse groups. Must work with diverse groups to obtain consensus on issues
The estimated pay scale for the Manufacturing Specialist role based in Los Angeles, CA, is $70,840 to $85,000 per year. Additionally, the position is eligible to participate in up to 5% of the company bonus pool. We offer a wide variety of benefits including, but not limited to: Medical, Dental, Vision, PTO, up to 5% 401(K) match and tuition reimbursement. Final compensation packages will ultimately depend on education, experience, skillset, knowledge, where the role is performed, internal equity and market data. We are committed to offering our employees opportunities for professional growth and career progression. Grifols is a global healthcare organization with employees in 30 countries focused on patient health and providing impactful results. Since our humble beginnings in 1909, Grifols has been a family company that prides itself on its family-like culture. Our company has more than tripled over the last 10 years, and you can grow with us!
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.
Third Party Agency and Recruiter Notice:
Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate.
Grifols provides equal employment opportunities to applicants and employees without regard to race; color; sex; gender identity; sexual orientation; religious practices and observances; national origin; pregnancy, childbirth, or related medical conditions; status as a protected veteran or spouse/family member of a protected veteran; or disability. We will consider for employment all qualified applicants in a manner consistent with the requirements of all applicable laws, including but not limited to, the California Fair Chance Act, the Los Angeles County Fair Chance Ordinance for Employers, and the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.
California Personnel Privacy Policy and Notice at Collection
Location: NORTH AMERICA : USA : CA-Los Angeles:USVALLEY - Valley Bl Mfg Plant - LA, CA
Learn more about Grifols (https://www.grifols.com/en/what-we-do)
Req ID: 530137
Type: Regular Full-Time
Job Category: Maintenance / General Services / Facilities
