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Manufacturing Process Specialist
2 months ago
We have an exciting opportunity for a talented Process Engineer. This role is a 12+ months contract position with potential for long-term engagement. Please find the details of the job description below.
Job ID:
Compensation: $64 - $74/hour. Employee benefits include health insurance (medical, dental, vision), 401(k) plan, and paid sick leave, depending on work location.
Key Responsibilities:
- Develop study protocols and technical documentation, revising process documents as necessary to facilitate technology transfer and process modifications.
- Conduct and assist in data monitoring of manufacturing processes to evaluate process capability.
- Assist in production-related investigations, ensuring adherence to internal standards and regulatory requirements.
- Examine completed batch records to confirm that processes are functioning within the validated state.
- Comprehend and manage tools and templates that quantify impact and criticality for parameters and attributes within Client and/or CMO unit operations.
- Ensure that manufacturing processes are controlled and standardized across the cell therapy network.
- Promote continuous improvement in both technical and business processes.
- Foster and maintain professional relationships with external partners.
Key Requirements and Technology Experience:
- B.S. or M.S. with 4-7 years of relevant experience in Biochemical, Chemical, or Biomedical Engineering or Cell Biology/Immunology discipline. (PhD candidates are considered overqualified)
- Experience with cellular therapies is highly preferred.
- 4+ years of proficiency in MS Office; experience with JMP is advantageous.
- 4+ years' experience in a regulated manufacturing environment is strongly preferred.
- 1+ years of experience in technical writing or deviation documentation.
- Flexibility to collaborate across East Coast and West Coast time zones.
- Excellent communication, writing, organizational, teamwork, and presentation skills.
- Exceptional interpersonal skills to engage with teams across various functions and organizations.
Pyramid Consulting, Inc. is a leading player in the Pharmaceutical Industry, and we are actively seeking to fill this and other similar contract roles. We provide equal employment opportunities to all employees and applicants for employment, prohibiting discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.
