Job Function: Supply Chain Manufacturing
Job Sub Function: Manufacturing Pharmaceutical Process Operations
Job Category:Professional
All Job Posting Locations:Wilson, North Carolina, United States of America
Job Description:We are searching for the best talent for a
Manufacturing Process Specialist to be based in
Wilson, NC.Role Summary:The
Manufacturing Process Specialist is responsible for performing technical expert supporting the manufacturing of biological products both on the site and across the network.
Key Responsibilities: Provides technical expertise to ensure that atypical event and non-conformance investigations relating to production and the testing of materials and products are completed in compliance with all applicable procedures and regulations. Monitors and trends key process parameters. Troubleshoots manufacturing problems as required and provide primary technical support. Identifies and implement process improvements both locally and across the network. Supports capital projects, site wide initiatives or other projects as needed in the capacity of a project manager or a subject matter expert. Conducts technical and validation studies.
- Provides primary (on floor) production support.
- Provides technical support for the investigation and resolution of deviations and atypical events:
- Partners with primary investigator to ensure consistent quality standards are maintained.
- Provides technical expertise to help identify true root cause of investigations and assess product quality impact. Approve investigations as management technical representative of Cell or COE, as needed.
- Recommends, owns 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 event.
- Collaborates with management to review and approve Cell or COE events and deviations.
- Tracks deviations, events and key process parameters and provide reports to management on trending, and status as requested. Recommends corrective actions for any trends identified.
- Act as subject matter expert (SME) to customers, providing guidance on deviations, investigations, and issues pertaining to quality of product.
- Identifies and implements process improvements related to safety, environmental, quality, compliance, productivity, yield, and cost. Implement process improvements within the change control system.
- Recognizes and acts on potential compliance issues and opportunities for process changes/improvement.
- Partners with all Cells and COE's to implement process improvements Work with management to allocate group resources to assist with change control, equipment startup, and technical training. Assure regulatory compliance and technical feasibility of proposed changes.
- Develops business cases for projects and present to site leadership for approval. Initiate and execute change controls for projects. Assist with equipment startup and technical training as required.
- Serves as project manager for the change process and provide coordination between Cell's and COE's to ensure timely and compliant implementation of process improvements.
- Shares best practices between production sites
- Provides technical support concerning the change control system.
- Provides technical support for process and cleaning validation maintenance and verification. Assist with cleaning cycle optimization and revalidation efforts.
- Serves as Subject Matter Expert (SME) during internal and external regulatory audits (including FDA, EMEA).
- Maintains various databases of production information:
- Extract process data from SCADA and Delta-V servers for use in databases maintained by technical operations.
- Use databases to monitor process performance and proactively troubleshoot operations. Work with Automation and Information Management to improve the effectiveness of process data collection and analysis.
- Coordinate data collection and trend analysis as requested by QA and Regulatory Affairs including the annual report required for maintenance of the Statistical Quality Control Database (SQC) and the Annual Product Review (APR).
- Demonstrates expertise in a number of the following areas: cGMPs, FDA regulations, cell banking, formulations, Cell culture, chromatographic purification, ultrafiltration, microfiltration, diafiltration, viral inactivation, filter integrity testing, CIP/SIP systems, or pharmaceutical water systems and utilities.
- Provide documentation support for SOP/ Batch Record revisions.
- Identify necessary document changes and provide to document management group to ensure timely revision to all SOP and batch records.
- Review and approve SOP and Batch record revisions for the Cell or COE.
Qualifications:- B.S. degree in technical area, with 5+ years' experience in a manufacturing environment, biopharmaceutical or pharmaceutical industry experience, or an equivalent combination of education and experience or relevant military experience.
- Independently performs investigations, process improvements, scheduling, training and document revisions.
- Identifies issues and implements resolutions.
- Assess data. Prepares and reviews documentation independently.
- Reviews and approves documents and investigations.
- Under vigorous data analysis and with support using more complex data mining techniques.
- Working knowledge of cGMP's in a biopharmaceutical or pharmaceutical manufacturing environment is preferred.
- The ability to apply basic project management skills to complete assigned projects effectively and consistently to meet challenging schedules is required.
- Influencing skills, partnering and collaboration skills, analytical skills and good oral and written presentation skills are required, with a demonstrated ability to work across organizational boundaries.
- Knowledge of FDA/EMEA regulatory requirements related to biologics and/or pharmaceuticals, preferred.
Other Requirements:- 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.
- Is frequently required to communicate with coworkers.
- Needs to perform gowning procedures in applicable areas
- Ability to stand, walk, sit, climb, bend, stoop, or reach with hands and arms for extended periods of time.
- Ability to lift, push or pull up to 40 lbs.
- Ability to interpret and carry out a variety of instructions furnished in written, oral, diagram or schedule form.
- Ability to interpret and carry out a variety of technical instructions in mathematical or diagram form.
- Ability to deal with nonverbal symbolism (formulas, scientific equations, graphs, etc.).
- Ability to define problems, collect data, establish facts and draw valid conclusions.
- Ability to deal with problems involving abstract and concrete variables in standardized situations.
- Ability to apply principles of logic or scientific thinking to intellectual and practical problems.
- This position will be designated for daytime work during project phase, though off-shift work may be required routinely. On Call support may be required on a rotational basis. Must be available for other duties as required
- During commercial phase, this position will be designated for off-hours (night) shift.
*This is not an exhaustive or comprehensive listing of job functions. May perform other duties as assigned.
#LI-Onsite
Required Skills: Preferred Skills:Agile Manufacturing, Analytics Dashboards, Business Behavior, Chemistry, Manufacturing, and Control (CMC), Communication, Competitive Landscape Analysis, Data Compilation, Data Savvy, Gap Analysis, Good Manufacturing Practices (GMP), Industry Analysis, Mentorship, Operational Excellence, Plant Operations, Problem Solving, Process Optimization, Project Administration, Technical Credibility
