Associate MPS (Entry-Level)

Johnson & Johnson•Wilson, NC

12h•Onsite

About The Position

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/ . We are searching for the best talent for an Associate Manufacturing Process Specialist (Entry-level) to be based in Wilson, NC. Role Summary The Manufacturing Process Specialist is a technical expert supporting the manufacturing of biological products both on the site and across the network. 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. This position requires strong organizational, communication and project management skills.

Requirements

B.S. degree, with 0-2 years of experience in a manufacturing environment, biopharmaceutical or pharmaceutical industry experience, or an equivalent combination of education and experience or equivalent military experience.
Experience in one or more area of bioprocess expertise of Protein purification, Ultrafiltration, Virus Filtration, Media and/or buffer preparation.
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.
Strong interpersonal skills to build productive relationships, collaborate effectively, and work well within a team while treating others with dignity and respect.
Flexibility and adaptability in a dynamic supply chain environment, with the ability to act quickly and with accountability to meet organizational goals.
Cultural sensitivity and ability to thrive in a multi-cultural and matrixed environment.
Knowledge of FDA/EMEA regulatory requirements related to biologics and/or pharmaceuticals, preferred.
Maintain high ethical standards and integrity through Credo-based actions.

Nice To Haves

Experience in Cleaning and Sterilization validation, preferred
Experience of Autoclaves and Sterilization, preferred

Responsibilities

Provides primary (on floor) production support for the resolution of technical issues, process improvement initiatives and business reliability.
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, 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 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.
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 to ensure timely and compliant implementation of process improvements.
Shares best practices between production sites
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/WIs/ 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.
Is responsible for the training of new staff members.
Carries out duties in compliance with all local, state and federal regulations and guidelines including FDA, EPA, and OSHA.
Complies with all company and site policies and procedure