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12 days ago
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Process Engineer


Simply Recruitment Partner
Salary band: $10k - $15k
Location: North America, United States, North Carolina, Charlotte
Job type: Permanent
Contact: Scientific Search
Category: Engineer
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Job Description:

Process Engineer Be sure to check out all of our other current openings at Process Engineer candidate with thorough understanding and wide application of technical principles, theories, and concepts in the field. Viewed as a technical resource in process development, process/equipment troubleshooting, process optimization/scale-up, and technology transfer. Has experience in modified and sustained release technologies for tablets and capsules, including matrix tablets, coatings, and multi-particulates.Design/develop and conduct studies to produce robust bio-equivalent product. Able to identify and evaluate critical formulation and process parameters, conduct statistical analyses, and utilize experimental design techniques. Write and review development and regulatory documents to support filings.Responsible for the management and execution of commercial product support projects in the areas of product technical transfer, product/process improvement and optimization, scale-up, troubleshooting and investigation. Write scientific documents to support justification for process scale-up, technology transfer, and/or equipment changes. Able to apply technical knowledge, creativity, and company practices to obtain solutions to complex problems while meeting project time lines.Develops and maintains common expectations for technical and behavioral performance of operators.Leads product/process development, technology transfer, scale-up, optimization, and improvement projectsPharmaceutical experience in Sterile Injectable operations, Oral Sold Dose with background in DQ/IQ/OQ/PQ qualification activities.Evaluates and develops new technologiesDevelops experimental plans for process development.Executes experimental, clinical, stability, and validation batches.Provides technical review of contracted and internal formulation and development work for transfer candidate products.Performs root cause identification of product/process related investigations.Performs process/equipment troubleshooting activities for daily support of manufacturing. Provides off hour on-call support to manufacturing.Uses judgment, creativity, and sound technical knowledge to obtain and recommend solutions/CAPAs.Authors development and investigation reports, protocols, specifications, procedures. Writes experimental, pivotal, validation/commercial batch records.Reviews GMP documents (MBRs, SOPs, RM specifications, protocols) and generates change controls.Works under limited supervision of management and/or team leads.Assist in writing proof of principle protocols, assist in writing and developing design specifications and IQ/OQ/PQ protocols. Experience and Education:Bachelor's degree or advanced degree in Science, Engineering, or Pharmaceutics.Minimum of 5 -7 years in formulation/process development, manufacturing support, scale-up, and technology transfer.Possesses project management skills; strong verbal and written communication skills.Possesses applied knowledge of root cause analysis and troubleshooting techniques. Able to apply statistical analyses and experimental design techniques. Technical competence and writing skills.Strong customer/quality focus. Knowledge of pharmaceutical GMPs and regulatory (FDA, DEA, OSHA) requirements. Adherence to all health, safety, and environmental requirements. Work in safe and efficient manner.Strong knowledge of 21-CFR-210, 21-CFR-211 and ICH GuidelinesVery strong knowledgeable in FDA regulations, industry Best Practices and FDA expectations.Proficient with MS Office.

Company Description:

Since 1983, Scientific Search has been placing technical, management, and executive level professionals. We have been named one of the fastest growing, privately held companies in South Jersey by the Philadelphia Business Journal six times, and one of the prestigious Philadelphia 100 companies on four occasions including this past year. We are also a member of the nationally recognized Inc. 5000. In 2015, we were recognized as one of the best places to work in NJ.
Job Description:

Process Engineer Be sure to check out all of our other current openings at Process Engineer candidate with thorough understanding and wide application of technical principles, theories, and concepts in the field. Viewed as a technical resource in process development, process/equipment troubleshooting, process optimization/scale-up, and technology transfer. Has experience in modified and sustained release technologies for tablets and capsules, including matrix tablets, coatings, and multi-particulates.Design/develop and conduct studies to produce robust bio-equivalent product. Able to identify and evaluate critical formulation and process parameters, conduct statistical analyses, and utilize experimental design techniques. Write and review development and regulatory documents to support filings.Responsible for the management and execution of commercial product support projects in the areas of product technical transfer, product/process improvement and optimization, scale-up, troubleshooting and investigation. Write scientific documents to support justification for process scale-up, technology transfer, and/or equipment changes. Able to apply technical knowledge, creativity, and company practices to obtain solutions to complex problems while meeting project time lines.Develops and maintains common expectations for technical and behavioral performance of operators.Leads product/process development, technology transfer, scale-up, optimization, and improvement projectsPharmaceutical experience in Sterile Injectable operations, Oral Sold Dose with background in DQ/IQ/OQ/PQ qualification activities.Evaluates and develops new technologiesDevelops experimental plans for process development.Executes experimental, clinical, stability, and validation batches.Provides technical review of contracted and internal formulation and development work for transfer candidate products.Performs root cause identification of product/process related investigations.Performs process/equipment troubleshooting activities for daily support of manufacturing. Provides off hour on-call support to manufacturing.Uses judgment, creativity, and sound technical knowledge to obtain and recommend solutions/CAPAs.Authors development and investigation reports, protocols, specifications, procedures. Writes experimental, pivotal, validation/commercial batch records.Reviews GMP documents (MBRs, SOPs, RM specifications, protocols) and generates change controls.Works under limited supervision of management and/or team leads.Assist in writing proof of principle protocols, assist in writing and developing design specifications and IQ/OQ/PQ protocols. Experience and Education:Bachelor's degree or advanced degree in Science, Engineering, or Pharmaceutics.Minimum of 5 -7 years in formulation/process development, manufacturing support, scale-up, and technology transfer.Possesses project management skills; strong verbal and written communication skills.Possesses applied knowledge of root cause analysis and troubleshooting techniques. Able to apply statistical analyses and experimental design techniques. Technical competence and writing skills.Strong customer/quality focus. Knowledge of pharmaceutical GMPs and regulatory (FDA, DEA, OSHA) requirements. Adherence to all health, safety, and environmental requirements. Work in safe and efficient manner.Strong knowledge of 21-CFR-210, 21-CFR-211 and ICH GuidelinesVery strong knowledgeable in FDA regulations, industry Best Practices and FDA expectations.Proficient with MS Office.

Company Description:

Since 1983, Scientific Search has been placing technical, management, and executive level professionals. We have been named one of the fastest growing, privately held companies in South Jersey by the Philadelphia Business Journal six times, and one of the prestigious Philadelphia 100 companies on four occasions including this past year. We are also a member of the nationally recognized Inc. 5000. In 2015, we were recognized as one of the best places to work in NJ.

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