Process Engineer

Process Engineer

Title: Process Engineer
Location: Brooksville, FL
Industry: Pharmaceutical
Salary: $80k and up depending on experience
Employment Type: Direct Placement

Client Overview:
Our Client is a US-based sterile injectable manufacturer of parenteral drugs with a world-class facility focused on ready-to-use pre-filled syringes and vials. The company's product line includes small molecule 505(b)(2) NDA and 505(j) ANDA syringe and vial products, and it serves as an outsourced contract manufacturing partner for strategic pharmaceutical companies.

Position Overview:
The Process Engineer will design, implement and optimize process strategies, managing process resources and maintaining process documents. The successful Process Engineer will have extensive experience in process design, excellent technical skills and high-level analytical skills, with the ability to analyze a process system and implement simple yet effective changes to boost production.
This position will be 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.
The Process Engineer will serve as a technical resource in process development, process equipment troubleshooting, process optimization, scale-up, and technology transfer in Sterile Injectables.

Responsibilities:

• Write scientific documents to support justification for process scale-up, technology transfer, and/or equipment changes.
• Support process validation batches by writing and executing process validation protocols and support Production during execution.
• Executes experimental, clinical, stability, and validation batches.
• Provides technical review of contracted and internal formulation and development work for transfer candidate products.
• Assess existing processes and draft process ideas to reduce costs and improve production rates
• Design and test process upgrades and new process systems
• Ensure processes comply with safety and quality standards
• Perform process simulations and troubleshoot issues
• Perform optimization tests and risk assessments
• Develop routines and best practices to ensure product quality
• Develop standardized operating instructions for the upgrades process
• Monitor upgrades systems
• Support production to maintain inventory flow and levels to meet demand
• Address issues (e.g., NCR, CAPA) quickly and effectively
• Plan, lead, and execute complex cross functional projects impacting operations and other areas of the business
• Lead continuous improvement activities of productivity, quality, cost, cycle time and yield of raw material
• Lead efforts to maintain and improve quality of existing operations, processes, and products
• Represent operations on new product development teams
• Develop and implement associated processes
• Analyze product or equipment specifications and performance requirements to determine feasibility of new plant equipment or modifying existing equipment
• Analysis and recommendations for capital equipment investments
• Utilize root cause analysis methods and statistical tools to resolve processing issues
• Use statistical methods to determine in-control/out-of-control processes
• Develop and implement methods and procedures for inspecting, testing and the evaluation of products for acceptability
• Lead the development and execution of equipment installation and operational qualifications
• Lead in the development and execution of process validations
• Lead in developing and maintaining support systems for production work processes
• Support integration of new business work processes
• Maintenance of the calibration program

• Bachelor s degree in Engineering or related science with 5 years of experience
• A minimum of 5 years of experience in Manufacturing Engineering, Process Design Engineering, Process Optimization, or Process Development, preferably in the pharmaceutical industry
• Experience with Quality Management Systems and Enterprise Resource Planning systems.
• Experience with process simulations and standard operating procedures
• Experience working with CAD and AutoCAD

• Proven project leadership / management skills required
• Excellent verbal, written and interpersonal skills
• An effective listener able to convey information in an accurate and concise manner and understand when to seek feedback
• Proficiency with MS Word, MS Excel, MS PowerPoint, MS Project, MS Visio required
• High-level knowledge of process engineering software systems
• Lean manufacturing and/or process controls experience a plus
• Advanced technical skills; analytical thinker
• Familiarity with state health and safety regulations
• Must have demonstrated hands-on experience in full lifecycle from system requirements and specification phase to design and implementation phase, and operational phase of computer system validation and qualification
• Must be resourceful with a strong customer-service orientation and commitment to provide timely and quality solutions to customer issues
• Must be well organized, self-directed, and a team player
• Must be detail-oriented, with strong analytical and problem-solving skills to effectively research, troubleshoot and solve challenging problems involving integrated systems
• Must possess a strong understanding of business processes related to pharmaceutical corporate activities
• Ability to work as part of a team and independently
• Displays a commitment to service, is process oriented and has a sense of urgency balanced with good judgement.
• Must possess the ability to quickly develop and maintain a high level of knowledge and understanding of customers existing solutions and documentation
• Strong integrity and work ethic are critical
• Demonstrated ability to deal with confidential information

• Must be able to lift or handle objects not more than 50 pounds to perform certain duties essential to the job function
• May be required to perform tasks essential to the job function in areas that require the use of personal protective equipment

• Must successfully complete all departmental training modules and meet the requirements as part of ongoing training

SRG offers flexible staffing solutions with a national presence. We provide contract, contract-to-hire, direct hire and executive search services. SRG utilizes an innovative approach to identify and qualify talent that is unique to the Staffing industry, featuring a cutting-edge platform that allows us to match professionals rapidly and precisely to client requirements. We have a proprietary database of over one million candidates and maintain continuous contact with our qualified talent.

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