Specialist 3 - Operations (contract)

$102,232 - $102,232/Yr

Jnj - Winterville, GA

Full-time - Mid Level

Winterville, GA

Food Services and Drinking Places

About the position

The Specialist 3 - Operations position at Johnson & Johnson is a contract role focused on providing technical support for the manufacturing processes of Active Pharmaceutical Ingredients (API), medical device raw materials, or medical device components. This role is critical in ensuring compliance with all applicable procedures and regulations while addressing atypical events and nonconformance investigations. The Specialist will work under limited direction from operations management and is expected to monitor and trend key process parameters, troubleshoot manufacturing problems, and identify and implement process improvements. Additionally, the Specialist will support capital projects and site-wide initiatives, acting as a project lead or subject matter expert as needed. In this role, the Specialist will provide primary production support, plan and control production schedules, and facilitate the implementation of production plans. They will take corrective actions for daily operational problems and act as a subject matter expert, guiding investigations and quality issues. The Specialist will also study existing processes to identify areas for improvement, recommend corrective measures, and ensure that all actions taken address the root causes of nonconformance events. The position requires collaboration with Quality Assurance to maintain consistent quality standards and involves tracking deviations and key process parameters, providing management with reports on trends and statuses. The Specialist will also be responsible for ensuring regulatory compliance and technical feasibility of proposed changes, initiating and executing change controls for projects, and improving process data collection and analysis. The role emphasizes the importance of safety, environmental compliance, and productivity, and requires the Specialist to connect inclusively within the department and across the company to address customer needs. The Specialist will also engage in personal and professional development, manage documentation for SOP and batch record revisions, and assist with equipment startup and technical training. They will demonstrate expertise in cGMPs, FDA regulations, and manufacturing processes, and will be responsible for handling controlled substances in compliance with applicable laws.

Responsibilities

• Provides primary (on floor) production support.
• Plans, prepares, issues, and controls production schedule and material requirements to ensure control flow of approved material timed to meet production plan.
• Facilitates the implementation of the production plan.
• Takes corrective action for daily operational problems within the department.
• Acts as subject matter expert (SME), providing guidance on deviations, investigations, and issues pertaining to quality of product.
• Studies the need for improvements of existing processes, systems, and equipment, and 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.
• Follows 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.
• 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.
• Assures regulatory compliance and technical feasibility of proposed changes.
• Initiates and executes change controls for projects.
• Retrieves and uses data to monitor process performance and proactively troubleshoot operations.
• Works with Automation and Information Management to improve the effectiveness of process data collection and analysis.
• Ensures department quality and safety compliance.
• Plans and directs the administration and implementation of assigned projects as required for the manufacture of the company's products.
• Connects inclusively within the department, with other departments, and within the company to address customer needs.
• Shapes the future through innovation by inspiring new ideas, trying new things, and demonstrating resilience and agility to adapt to change.
• Grows by developing self and others to reach goals by engaging in open and honest conversations, managing energy, and taking ownership for outcomes.
• Provides documentation support for SOP/Batch Record revisions.
• Identifies necessary document changes and ensures timely revision to all SOP and batch records.
• Reviews and approves SOP and batch record revisions.
• Assists with equipment startup and technical training as required.
• Provides technical support for process and cleaning validation maintenance and verification.
• Assists with cleaning cycle optimization and revalidation efforts.

Requirements

• High school education/GED plus two years formal technical education/training or equivalent; Bachelor's degree in science preferred.
• Generally, 4-6 years of work experience in a chemical, pharmaceutical, medical device or similarly regulated manufacturing industry.
• Ability to learn and operate SAP Production, COMET, SUMMIT, to the level required.
• 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.

Nice-to-haves

• 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.

Benefits

• Health Insurance
• Life insurance
• 401K
• Voluntary Benefits