Job Description:
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 the 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, undertake optimization to increase efficiency and quality and to reduce costs.
• Recommends and implements corrective/preventative measures aimed at improving compliance and reducing repeat occurrences.
• 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.
• Live Our Credo and Purpose by putting the need of Our Credo; stakeholders first, pursuing the highest standards of compliance, quality and ethics.
• 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.
Requirements:
• 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.
Qualification:
• High school education/GED plus two years of formal technical education/training or; Equivalent
• Bachelor’s degree in science preferred.
Experience and Skills:
• 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.
Preferred:
• Experience with SAP and Minitab.
• Experience with process control systems (e.g. PCS 7, Emerson DeltaV) and data historian software (e.g. OSi PI).
• Solid understanding of Word, PowerPoint, and Excel.