Project Engineer, Quality Engineering

Applications are sought for a Raw Material Planner Sr. Specialist within Planning and Manufacturing Systems (PAMS) in our Company's Research & Development Bioprocess Clinical Manufacturing and Technology (BCMT). The individual will support pilot-scale campaigns for the GMP manufacture of bulk biologic (vaccines, therapeutic proteins, monoclonal antibodies) clinical supplies.

Primary responsibilities include establishing priorities for raw material (RM) procurement and procuring RM internally (our Company's Manufacturing, our Company's Research & Development network) or externally (outside vendors), coordinating culture media (CM)/buffer manufacturing, collaborating and partnering across the network (internal and external) to benchmark, understand, influence, and execute standards of RM management, coordinating RM/CM deliveries to and from Biological Support Operations (BSO) and to VAX Process Research and Development (VAX PR&D) bulk manufacturing suites (including the Biologics Pilot Plant - BPP), tracking and managing inventory of RMs and GMP Supplies (including single-use technology), managing RM/CM storage space, collaborating with the Process Development team to determine critical parameters, and performing CM laboratory studies (as determined).

Candidate may participate in a range of activities including, but not limited to, SOP development, support of new IT initiatives, and Supply Chain management of RMs and GMP Supplies.

Excellent understanding of the regulatory guidelines governing GMP manufacture is required.

Candidate is expected to work in a team atmosphere in close collaboration with Process Development groups, Facility Engineering, RM/CM Release, Procurement (our Company's Manufacturing, our Company's Research & Development network, and outside vendors). Overtime and off-shift work may be required.

• BS degree in Engineering, Sciences, Business, or a related field with minimum 5 years of relevant experience or a master's degree with 3 years of relevant experience

• Ability and desire to work in a fast-paced and dynamic pilot plant environment that demands out-of-box thinking, prioritization, and rapid response to events and situations
• Direct experience with working with SAP/PASX
• Strong understanding of manufacturing principles/processes through work experience
• Ability to work collaboratively as part of a team across various functions in a challenging and changing global environment
• Proven track record of analytical skills, problem solving, and attention to detail
• High personal integrity, credibility, and energy
• Strong written and verbal communication skills

• Experience in pharma/sterile manufacturing

Adaptability, Analytical Testing, Data Analysis, Detail-Oriented, Deviation Management, Equipment Qualification, Good Manufacturing Practices (GMP), Process Design, Process Hazard Analysis (PHA), Process Optimization, Root Cause Analysis (RCA), Strategic Thinking, Technical Leadership, Technical Problem-Solving, Technical Writing

US and Puerto Rico Residents Only:
Candidates who meet these residency requirements should ensure compliance with applicable regulations.

San Francisco Residents Only:
We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance.

Los Angeles Residents Only:
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.

We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare, and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days.

Salary range: $ - $. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.

For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights, EEOC GINA Supplement, Learn more about your rights, including under California, Colorado and other US State Acts.