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