Deviation Investigator Jobs (NOW HIRING)

Qualifications:
Education Minimum Requirements:
• B.S. degree in Engineering or Sciences.
Required Experience and Skills:
• Minimum one (1)+ year post-bachelor's degree experience in a GMP (good manufacturing practices) manufacturing and/or technical support of GMP manufacturing operations (or M.S. degree with ?1 year experience).
• Demonstrated ability to drive results to hit assigned due dates.
• Strong communication, collaboration skills and ability to drive accountability.
• Strong problem-solving skillset.
Preferred Experience and Skills:
• Vaccine manufacturing
• Sterile processing
• Technical writing (e.g. investigations, technical protocols/reports)
• Investigative tools (e.g. 5-whys, fishbone)
• Experience authoring investigations for atypical events in a manufacturing environment
Responsibilities:
The Deviation Management Contractor will be responsible for technical support to vaccine manufacturing. This engineer will be a member of the Technical Operations Deviation Management team within the manufacturing division at the West Point site. The primary responsibility of the individual will be investigation initiation and closure associated with manufacturing deviations and development of actions in response to these deviations (i.e. identifying root cause, recommending corrective/preventative actions, assessing product impact, and summarizing investigations in writing). Support will be focused on the Deviation Management process including operations support, equipment troubleshooting, implementation of process/equipment actions, and other related duties. This position will require development of technical expertise of process and product knowledge.
This position is a site-based assignment and requires the employee to work at the site M-F. Two days of remote work per week may be available, work permitting, but is not guaranteed. Off-shift or weekend coverage may be required based on business unit needs and specific assignments.
Responsibilities include:
• Leads and/or works as a team member on deviation investigations aimed to prevent deviation recurrence, including determining the root cause, identifying corrective/preventative actions, identifying event scope, and conducting product impact assessment.
• Has ability to examine an issue from diverse perspectives (safety, compliance, automation, equipment, process, and people) in order to best understand and resolve the root cause.
• Supports and/or executes continuous improvement projects that increase compliance, simplify/ standardize, and/or gain efficiencies.
• Manages timelines to ensure key compliance and customer due dates are met; escalates any potential misses and develops remediation plans when possible.
• Assures consistent application of standardized work, engineering, and process tools.
• Provides technical support to manufacturing shop floor for problems and issues.
• Conducts and designs experimental protocols as needed using the Technical Operations lab facilities and/or production equipment at full scale.
• Authors and updates technical and manufacturing documents necessary for investigations, process design/definition, engineering studies, process demonstrations, change control and validation. Equal Opportunity Employer / Disabled / Protected Veterans
The Know Your Rights poster is available here:
https://www.eeoc.gov/sites/default/files/2023-06/22-088_EEOC_KnowYourRights6.12.pdf
The pay transparency policy is available here:
https://www.dol.gov/sites/dolgov/files/ofccp/pdf/pay-transp_%20English_formattedESQA508c.pdf
For temporary assignments lasting 13 weeks or longer, AllSTEM Connections is pleased to offer major medical, dental, vision, 401k and any statutory sick pay where required.
We are committed to working with and providing reasonable accommodations to individuals with disabilities. If you need a reasonable accommodation for any part of the employment process, please contact your staffing representative who will reach out to our HR team.
AllSTEM Connections participates in the E-Verify program in certain locations as required by law. Learn more about the E-Verify program.
https://e-verify.uscis.gov/web/media/resourcesContents/E-Verify_Participation_Poster_ES.pdf
We also consider for employment qualified applicants regardless of criminal histories, consistent with legal requirements, including, if applicable, the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance. Pursuant to applicable state and municipal Fair Chance Laws and Ordinances, we will consider for employment-qualified applicants with arrest and conviction records, including, if applicable, the San Francisco Fair Chance Ordinance. For Los Angeles, CA applicants: Qualified applications with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.
Additional Skills
(none specified)
AllSTEM Representative Contact Info
Account Executive:
Broughton
Branch Phone:
(909) 244-1777
Location:
Ontario, CA