Process Engineering Specialist (contract)
Johnson & Johnson Family of Companies
Title: Process Engineering Specialist
Location: Athens, GA - 100% Onsite
Duration: 15 months
Pay Rate: $49.15
Benefits on offer for this contract position: Health Insurance, Life insurance, 401K and Voluntary Benefits
Please note that this is a contract role providing services to the Johnson & Johnson Family of Companies through external staffing partners of Kelly OCG. If you are selected for this role, you will be employed by a contract staffing supplier and will not be a member of the Johnson & Johnson Family of Companies.
Summary:
The Process Specialist is the technical expert who is responsible for providing technical support for the Active Pharmaceutical Ingredient (API), medical device raw material or medical device component manufacturing processes under limited direction of operations management. These responsibilities include providing technical expertise to ensure that atypical event and nonconformance investigations relating to production are completed in compliance with all applicable procedures and regulations, monitors and trends key process parameters, troubleshoots manufacturing problems as required and identifies and implements process improvements, supports capital projects, site wide initiatives or other projects as needed in the capacity of a project lead or a subject matter expert and conducts technical and validation studies.
Responsibilities:
• Provides primary (on floor) production support.
• Plan, prepare, issue, and control production schedule and material requirements to ensure control flow of approved material timed to meet production plan.
• Facilitate the implementation of the production plan.
• Takes corrective action for daily operational problems within the department.
• Act as subject matter expert (SME), providing guidance on deviations, investigations, and issues pertaining to quality of product.
• Study the need for improvements of existing processes, systems and equipment, and in cooperation with related departments, undertakes optimization to increase efficiency and quality and to reduce costs.
• Recommends and implements corrective/preventative measures aimed at improving compliance and reducing repeat occurrences. Follow up to determine if corrective actions adequately addressed root cause of NC event.
• Provides technical support for the investigation and resolution of deviations and atypical events by partnering with Quality Assurance to ensure consistent quality standards are maintained.
• Tracks deviations, events and key process parameters and provides reports to management on trending, and status as requested.
• Recommends corrective actions for any trends identified.
• Identifies and implements process improvements related to safety, environmental, quality, compliance, productivity, yield, and cost.
• Assure regulatory compliance and technical feasibility of proposed changes.
• Initiate and execute change controls for projects. Retrieve and use data to monitor process performance and proactively troubleshoot operations.
• Work with Automation and Information Management to improve the effectiveness of process data collection and analysis.
• Ensure department quality and safety compliance.
• Plan and direct the administration and implementation of assigned projects as required for the manufacture of the company's products.
• Connect inclusively within the department, with other departments, and within the; company to address customer needs.
• Shape the future through innovation by inspiring new ideas, trying new things, and demonstrating resilience and agility to adapt to change.
• Grow by developing self and others to reach goals by engaging in open and honest; conversations, managing energy, and taking ownership for outcomes.
• Provide documentation support for SOP/ Batch Record revisions.
• Identify necessary document changes and ensure timely revision to all SOP and batch records.
• Review and approve SOP and batch record revisions.
• Assist with equipment startup and technical training as required.
• Provide technical support for process and cleaning validation maintenance and verification. Assist with cleaning cycle optimization and revalidation efforts.
• Demonstrates expertise in the following areas: cGMPs, FDA regulations, manufacturing; processes, manufacturing equipment, high purity water systems, and utilities.
• Responsible for handling controlled substances in compliance with applicable State and local law and requirement.
Qualifications:
• Bachelor’s degree in any science related background required.
• 2+ years of work experience in a chemical, pharmaceutical, medical device or similarly regulated manufacturing industry.
• Ability to learn and operate SAP Production highly preferred
• Technical understanding of at least one processing area.
• Ability to read, analyze and interpret procedure manuals, common scientific and technical journals, basic financial reports and legal documents, general business periodicals and government regulations.
• Ability to respond to sensitive inquiries and present information to Site Management, regulatory agencies and members of the business community.
• Ability to define problems, collect relevant data and information, establish facts, and draw valid conclusions as required.
• Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
• Demonstrated ability to write effectively to communicate work prepared, rationalize conclusions and recommendations, and compliantly document for regulatory bodies.
• Manage and coordinate multiple project priorities as required.
• Ability to work independently on routine and non-routine tasks.
• Successfully completes regulatory and job training requirements.
• Remains current in skills and industry trends
• Experience with SAP and Minitab is preferred
• Experience with process control systems (e.g. PCS 7, Emerson DeltaV) and data historian software (e.g. OSi PI) is preferred.
• Solid understanding of Word, Power Point, and Excel is preferred
• Required to move around the manufacturing plant to perform on-site investigations.
• Needs to perform gowning procedures to work in manufacturing core.
• Off-shift work or on-call support may be required.
• Must be available for other duties as required.
Hospitals and Health Care
Engineering and Information Technology
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