Specialist 3 Operations Engineering - Katalyst Healthcares & Life Sciences

• The Process Specialist is the technical expert who is responsible for providing technical 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.

• Ensure department quality and safety compliance.;

• 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.;

Requirements:

• 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

• Experience with SAP and Minitab.

• Solid understanding of Word, Power Point, and Excel.

• Other Requirements:

• Regularly required to talk and hear, stand, walk, sit, use tactical sense, handle, or feel,

• and reach with hands and arms.

• Required to move around the manufacturing plant to perform on-site investigations.

• Needs to perform gowning procedures to work in manufacturing core.

• Specific vision abilities required by this job include close vision, distance vision, depth

• perception, and ability to adjust focus.

• Off-shift work may be required. On-call support may be required. Must be available for other duties as required.

• Travel Requirements: up to 10% domestic/international

• Needs to be mobile and able to independently transport themselves between various sites/locations, as dictated by the essential functions and responsibilities of the position.

• Technical Writing

• Nonconformance investigation documentation

• Continuous improvement projects

• Creating/Updating SOPs

• Working on Training projects and developing a clean parts management process for Operations