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Manufacturing Process Engineer

at Acara Solutions in Newark, Delaware, United States

Job Description

Acara Solutions is looking for a Manufacturing Process Engineer for our client located in Newark, DE
This role is for a person to engage as part of a team with Client staff to participate in the development and commissioning of production processes for the manufacture of biochemical reagents, calibrator and control products and other fluidic chemical compounds and then to assist in the transfer of new products into those facilities.
In addition to understanding process design considerations the candidate be assist in the validation of associated equipment and process steps including helping to develop IQ, OQ and PQ validation protocols and then executing such protocols.
Additionally, it will be expected that the successful candidate will have the ability to drive cross-functional PFMEA reviews and participate in process hazard reviews.
A person in this role will also be expected to assist in the transfer of new products into these facilities and to establish the operating instructions to guide formulation, filling, packaging and testing of products produced with these facilities.
Evaluation of process equipment to produce custom formulated liquid reagents as well as automated material handling equipment to label and package final product
Physical/chemical characterization of product, metrology, performance testing and working with team to correlate impact of process parameters on end-use product.
Documentation of processes, validations and authoring technical protocols, reports and testing procedures in a regulatory-compliant environment.
Development of/or management of external partners that produce critical raw materials
Interpreting analysis of instrument-chemistry interactions for clinical chemistry methods to understand sensitivities of product to manufacturing processes.
Lead and conduct troubleshooting activities as necessary to determine the root cause for failures and identify and verify corrective actions. Must be familiar with design change, design verification and validation requirements for products and processes.
Should be able to plan and execute assay verification and validation studies
Pay and Benefits:

The Salary for this position $45.00 per hour (Max Pay rate).


Required Skills / Qualifications:
Minimum of a bachelor's degree
Minimum of 4 years' experience in In-vitro diagnostic or pharmaceutical product manufacture.
Minimum of 4 years' experience in Manufacturing, compounding, and processing of pharmaceuticals
Minimum of 4 years' experience with biochemical/chemical manufacturing, fluid process design (precision dispensing/filling equipment, mixing, filtering) fluid test/analysis methodologies (conductivity, flow, IR, HPLC), electrochemistry/electrochemical sensor manufacture, tableting, physical pharmacy
Minimum of 4 years' experience in the development of chemical/biochemical processes.

Preferred Skills / Qualifications:
Minimum of 3 years direct experience in the development of manufacturing processes for biochemical reagents or pharmaceuticals and Applied knowledge
Specific experience in the manufacture of products used in clinical diagnostics
Experience in Project Management training
Experience in experimental design, use of DOE and statistical analysis software.
Knowledge of statistical Process Control is necessary.
Position will be as an individual contributor - no personnel management experience is needed; however it is expected that the person will have excellent oral and written communication skills and be able to effectively function as part of a broad cross-functional team.
Have knowledge in the development of chemical/biochemical processes.
Technical focus should be in Biochemical Engineering, Biochemistry or Chemical Engineering.
Should be knowledgeable about FDA and other external regulatory agency requirement including cGMP, familiar with safety aspects of biohazardous materials; provide technical support for regulatory submissions/registrations.
Apply scientific and statistical principles and provide technical leadership to perform a wide variety of technical investigations arising out of reagent performance issues encountered during reagent manufacturing.
Working knowledge of clinical chemistry and application of automated assays in clinical chemistry laboratories.
Ability to build strong working relationships in cross-functional project teams to develop technical solutions to problems
Additional Information:

Upon offer of... For full info follow application link.

Aleron companies; Acara Solutions, Aleron Shared Resources, Broadleaf Results, Lume Strategies, Viaduct, and Aleron's strategic partner, SDI are Equal Employment Opportunity and Affirmative Action Employers. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender identity, sexual orientation, national origin, genetic information, sex, age, disability, veteran status, or any other legally protected basis.

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Job Posting: 1076329

Posted On: Nov 20, 2022

Updated On: Dec 20, 2022

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