Process Engineer

Spectraforce

Frederick, Maryland


a month ago

Similar Jobs
Process Engineer
Spectraforce
Frederick, Maryland

a month ago

Job Description

Job Title: Process Engineer – Manufacturing Investigations
Location - Frederick, MD, 21704
Duration- 12 Months 


Responsibilities Include (but are not limited to):
• Complete required training to maintain technical skill, knowledge, and compliance with cGMP requirements.
• Initiate quality records in the Veeva Quality Management System (QMS).
• Lead cross-function team meetings to perform complex root cause analysis (RCA).
• Compile investigation results in a concise and comprehensive technical report format.
• Collaborate with stakeholders to develop Corrective and Preventive Actions (CAPA).
• Manage investigation timelines to meet/exceed site compliance metrics for closure adherence.
• Provide timely progress updates to internal stakeholders, as required.
Basic Qualifications:
  • BS or BA in Biochemical Engineering, Chemical Engineering, Biotechnology, Chemistry, Biology, or equivalent with at least 2 years of relevant experience or
  • AA in Biochemical Engineering, Chemical Engineering, Biotechnology, Chemistry, Biology, or equivalent with at least 6 years of relevant experience or
  • HS Diploma with 8 years of relevant experience in Biochemical Engineering, Chemical Engineering, Biotechnology, Chemistry, Biology, or equivalent
Preferred Qualifications:
• Strong skills in technical writing
• Strong skill in organization
• Strong skill in root cause analysis
• Experience in cell culture or aseptic processing
• Experience in cGMP cell therapy manufacturing 

About Us: Established in 2004, SPECTRAFORCE® is one of the largest and fastest-growing diversity-owned staffing firms in the US. The growth of our company is a direct result of our global client service delivery model that is powered by our state-of-the-art A.I. proprietary talent acquisition platform, robust ISO 9001:2015/ISO 27001 certified processes, and strong and passionate client engaged teams. We have built our business by providing talent and project-based solutions, including Contingent, Permanent, and Statement of Work (SOW) services to over 140 clients in the US, Canada, Puerto Rico, Costa Rica, and India. Key industries that we service include Technology, Financial Services, Life Sciences, Healthcare, Telecom, Retail, Utilities and Transportation. SPECTRAFORCE is built on a concept of “human connection,” defined by our branding attitude of NEWJOBPHORIA®, which is the excitement of bringing joy and freedom to the work lifestyle so our people and clients can reach their highest potential. Learn more at: http://www.spectraforce.com
 
Benefits: SPECTRAFORCE offers ACA compliant health benefits as well as dental, vision, accident, critical illness, voluntary life, and hospital indemnity insurances to eligible employees. Additional benefits offered to eligible employees include commuter benefits, 401K plan with matching, and a referral bonus program. SPECTRAFORCE provides unpaid leave as well as paid sick leave when required by law.

Equal Opportunity Employer: SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at LOA@spectraforce.com if you require reasonable accommodation. 
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $38.00/hr.