Process Engineer - Technical Operations Job
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Job Tile: Technical Operations Process Engineer - Solid Dosage
Job Number: 2016-45431
Date Posted: 12-8-2016
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The Technical Operations Process Engineer is responsible for supporting Solid Dosage manufacturing operations with technical and quality expertise. The expertise may include the following areas: Manufacturing Documentation, Processing and process controls, materials, formulations and operating environment. The expertise is to be applied to maximize product quality, cost reduction, improve overall efficiencies in department and ensure manufacturability of formulas released for production operations remain reliable and repeatable through proven sustained performance. The position is also responsible for reviewing changes in manufacturing processes and raw materials to help minimize potential negative impact to quality of products throughout production process. Core expectations of this position include formula review, trouble shooting formula related manufacturing issues, quick modifications to correction manufacturability issues, review of new or replacement raw materials, collaborating with production team regularly, and maintaining and growing expertise in their relevant field(s).The position may require additional work hours and/or including weekends as necessary for supporting Solid Dosage manufacturing operations.
Essential Duties and Responsibilities:
- Foster a continuous improvement environment by evaluating and recommending on-going quality and efficiency improvements as it relates to process/engineer/formulation changes, machinery, documentation, machine utilization, manufacturing environmental conditions and safety best practices
- Collaboration with product development technicians, formulators and scientist to ensure continuous improvement, continuity of experience, troubleshooting skills, and scientific knowledge
- Collaboration with Solid Dosage Production team and ability to elevate problems to Managers/Departments when situation requires
- Maintain confidentiality of research and product development, trade secrets, government reporting and legal matters, and strategic quality initiatives
- Review of formulations to improve overall manufacturability and efficiency
- Monitoring of all work centers in Solid Dosage to ensure quality and provide tech support where required
- Evaluation of problematic formulas/machines/processes to determine if replacement or modified equipment is needed to meet manufacturing requirements and improve right first time quality of formulas
- and first pass yields
- Help customer expectations by monitoring production and quickly adjusting manufacturing issues
- Maintain/Improve industry knowledge to ensure that the company is able to take advantage of new technologies and or scientific breakthroughs
- Provide first line technical support for Solid Dosage areas that include, Blending, Compression, Coating and Hardshell to support the production of products right the first time.
- Promote an environment of teamwork within all the departments to ensure effective and efficient company operations
- Participate in investigations resulting from manufacturing deviations, CAPAs, audit observations, manufacturing exceptions and trend analysis data. In response to these investigations develop and implement immediate corrections, in addition to short term and long term solutions following appropriate change control procedures for sustainability
- Design and implement process and yield improvement studies for underperforming product codes as well as implement the study a focus on continuous improvement, problem solving may range from simple to multi-layered, matrixed conditions requiring in depth problem solving skills
- Analyze data and Solid Dosage product trends to identify areas of improvement in quality systems, compliance and production efficiencies
- Initiate MCR’s, edit MBR’s, edit Formula A-Pages and generate deviations
- Analyze raw material supplier performance and material data to identify quality improvement opportunities
- Coach and mentor process technicians and Solid Dosage production team to facilitate continuous improvement and expand their technical understanding
- Participate in training, Technical documentation/deviation writing and formal investigations
- Comply with Company standards, SOPs, and CGMPs
- Perform and assist with special non-routine project assignments; Communicate to all levels of organization.
- This position has no supervisory responsibilities
- 3-5 years’ experience in manufacture/quality monitoring of dosage forms
- BS degree in Engineering, Chemistry, Biology, Pharmacy or science-related field
- Lean Manufacturing(Six Sigma) training or certification preferred
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Reasonable accommodations as requested may be made to enable individuals with disabilities to perform the essential functions.
- Strong team player and motivated problem solver
- Excellent ability to troubleshoot
- Clear and concise communication skills
- Proficiency in computer software applications: MS Word, Excel, and PowerPoingt
- Ability to constructively interact with others to resolve issues and improve issues and improve the operation
- Strong organizational, communication, and analytical skills
- 3-5 Years’ experience in manufacturing/monitoring Quality
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to talk or hear and sit. The employee is occasionally required to reach with hands and arms. Specific vision abilities required by this job include close vision.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is usually moderate.