Overview
On Site
Full Time
Skills
STL
IT Operations
Analytical Skill
Training
Biomedicine
Life Sciences
Chemistry
Biology
GMP
Manufacturing
Attention To Detail
Management
Effective Communication
Innovation
Workflow
SAP BASIS
Military
Law
Recruiting
Promotions
Human Resources
Legal
Regulatory Compliance
Reporting
Job Details
Work Location: St. Louis, Missouri
Shift:
Department: LS-SC-POKMA1 Cherokee STL Technical Operations 2
Recruiter: Ashley Hennessy
This information is for internals only. Please do not share outside of the organization.
Your Role:
The Process Engineer is responsible for developing the manufacturing process train for custom bioconjugation products in GMP manufacturing and bringing in new manufacturing equipment. This role works cross-functionally with Manufacturing, Process and Analytical Development, Engineering, Validation, and customers to determine process needs and requirements for transferring production processes into the GMP space.
Who You Are:
Minimum Qualifications:
Preferred Qualifications:
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.
Shift:
Department: LS-SC-POKMA1 Cherokee STL Technical Operations 2
Recruiter: Ashley Hennessy
This information is for internals only. Please do not share outside of the organization.
Your Role:
The Process Engineer is responsible for developing the manufacturing process train for custom bioconjugation products in GMP manufacturing and bringing in new manufacturing equipment. This role works cross-functionally with Manufacturing, Process and Analytical Development, Engineering, Validation, and customers to determine process needs and requirements for transferring production processes into the GMP space.
- Assesses facility fit, equipment needs, and manufacturing capabilities for potential new products
- Determines process needs/requirements for processes moving from Development to GMP
- Creates detailed process overviews and flow diagrams
- Identifies and orders equipment for use in GMP manufacturing
- Establishes manufacturing equipment specifications
- Generates, reviews, and approves engineering, manufacturing, and quality procedures necessary to support equipment qualification and operation of equipment in GMP manufacturing (procedures and product-specific recipes)
- Initiates, reviews/approves equipment change requests
- Develops and/or implements systems improvement projects and supports Maintenance and Manufacturing groups in resolving technical and engineering issues
- Supports Manufacturing and Maintenance groups in troubleshooting manufacturing equipment
- Supports Validation in Equipment and Process Validation activities per GMP regulations
- Facilitates training for individuals involved in the operation and maintenance of processes and equipment introduced to the manufacturing department
Who You Are:
Minimum Qualifications:
- Bachelor's Degree in Engineering (Chemical, Biomedical, etc.) or Life Science (Chemistry, Biology, etc.)
- 2+ years' experience in GMP Operations
Preferred Qualifications:
- Comprehensive technical knowledge and understanding of GMP manufacturing equipment and biologics production processes
- Experience with AKTA and Mobius systems
- Excellent attention to detail and ability to effectively manage multiple projects
- Effective communication and engagement skills (verbal, written, listening)
- Ability to work with internal departments and customers
- Ability to build a culture of trust and business driven innovation
- Ability to work with internal organizations to solve on-going issues within the team
- Ability to communicate and lend guidance on day-to-day workflow to overcome challenges related to completing projects
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.
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