Sr. Process Engineer
As our Senior Process Engineer, you will work in a fast-paced environment and play a key role in ensuring engineering and technical services objectives and milestones are achieved. You will collaborate and communicate across the organization to implement and oversee all engineering services and related activities to ensure on-time completion and high-quality deliverables.
- Implement and oversee all engineering and technical services objectives. Responsible for the technical productivity agenda.
- Collaborate with cross-functional teams to improve processes by providing technical and scientific support as needed.
- Perform monitoring of process parameters and product data; assess and understand process capability.
- Assist in the creation of master batch records, process SOPs, product quality reviews, distribution temperature profiles, and applicable technical documents to support the control strategy of the products.
- Responsible for the technical product transfer from formulation development to clinical and commercial. Responsible for the creation of Process Validation protocols and reports.
- Participate as the technical subject matter expert (SME) in process meetings with customers. Provide technical input on the following processes: formulation, filtration, filling, lyophilization, sterilization, and depyrogenation.
- Provide technical input on investigations to determine product impact. Determine root cause using recommended tools (fishbone, fault tree analysis) and implement effective CAPAs.
- Assess proposed manufacturing changes against the control strategy. Evaluate the level of impact and recommend the implementation plan, as necessary.
- B.S. or M.S. in Chemical or Mechanical Engineering or another related discipline
- Five years of experience working in a sterile manufacturing environment
- Knowledge of cGMP, USP, Ph. Eur., FDA, and ICH requirements and regulations as they apply to the production of drug products
- Experience with syringe and vial filling with isolator technology processes
- Experience with sterilization (autoclave, VHP, product TS, filtration), process (PV) and cleaning validation
- Experience using statistical tools for process analysis
- Candidate must have experience managing projects with minor supervision
- Excellent written, verbal, and interpersonal skills
TriPharm Services, Inc. is an equal opportunity employer committed to providing employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age or disability, or any other class protected by Federal, State or local laws. TriPharm complies with all employment eligibility verification requirements of the Immigration and Nationality Act, and all must have the authorization to work in the U.S.