Associate Manufacturing Process Specialist

Johnson & Johnson Innovative Medicine•Athens, GA

1d•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 jnj.com. As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. We are searching for the best talent for an Associate Manufacturing Process Specialist! This onsite position will be located in Athens, Georgia. Join a team committed to delivering trusted therapies to the patients who need them most. In this role, you’ll work alongside dedicated colleagues who care deeply about doing what’s right and continuously improving the way we operate. Ready to make an impact? Apply today! The Associate Manufacturing Process Specialist is responsible for providing technical expertise and on-floor support for the Active Pharmaceutical Ingredient (API), medical device raw material, or medical device component manufacturing processes. Under direction of operations management, they will lead and support investigations, resolve atypical event and non-conformances related to production, monitor and trend key process parameters, and identify and implement process and equipment improvements. The Specialist also will support technical and validation studies/activities, troubleshooting, capital projects, and other site initiatives as a project lead or a subject matter expert (SME) to ensure efficient manufacturing operations while adhering to safety and compliance standards.

Requirements

Minimum of a High School Diploma or equivalent diploma/degree required; Associate's, Trade/Technical, Vocational, Bachelor's, or equivalent degree/diploma/certification strongly preferred
Minimum 6 months of relevant experience (including work experience, internship, Co-op, or research roles)
Experience within Chemical, Pharmaceutical, Medical Device, or similarly regulated manufacturing industry
Understanding of manufacturing processes, process validation, and continuous improvement methodologies
Experience in identifying, analyzing, and leading process enhancements for safety, quality, and/or cost
Solid understanding of Word, Power Point, and Excel
Ability to lead, coordinate, and collaborate on cross-functional projects while ensuring multiple project priorities are met
Ability to respond to sensitive inquiries and present information to Site Management Regulatory agencies, and members of business community
Ability to work independently on routine and complex issues
Ability to define problems, collect relevant data and information, establish facts, and draw conclusions
Demonstrated ability to write effectively to communicate work prepared, rationalize conclusions and recommendations, and compliantly document for regulatory bodies
Required to move around the manufacturing plant to perform on-site investigations
Specific vision abilities required by this job include close vision, distance vision, depth perception, and ability to adjust focus
Requires the ability to report for off-shift work and on-call support, and must be available for other duties as required
Requires up to 10% domestic/international travel and requires ability to independently travel between various sites/locations, as needed by the essential functions and responsibilities of the position

Nice To Haves

Experience in performing investigations, root cause analyses, and problem solving in a GMP environment
Demonstrated ability to define and implement Corrective and Preventive Actions (CAPAs) and drive process improvements
Knowledge of regulatory compliance standards (FDA, EMEA, DEA) and audit readiness
Ability to use statistical analysis tools such as Minitab, Power BI, or similar software to analyze process data, including multivariate analysis
Experience working with SAP for production and troubleshooting of SAP transactions
Familiarity with Comet (for reporting transactions)
Experience with process control systems (e.g., Emerson DeltaV) and data historian software (e.g. OSi PI)

Responsibilities

Provide primary on‑floor production support to ensure safe, compliant, and efficient operations
Plan, prepare, and control production schedules and material requirements and ensure effective implementation of the manufacturing plan
Take corrective action to resolve daily operational issues within the department
Lead and provide SME support for deviations, non‑conformances, investigations, and root‑cause analyses, partnering with Quality to ensure consistent and compliant resolution
Recommend, implement, and verify corrective and preventive actions (CAPA), monitor trends in deviations and key process parameters, and report findings to management
Evaluate and optimize processes, systems, and equipment to improve safety, quality, compliance, productivity, yield, and cost efficiency
Retrieve, analyze, and use process data to monitor performance and proactively troubleshoot operations, working with Automation and Information Management to improve data collection and analysis
Lead assigned projects, including initiation and execution of change controls, to support manufacturing and operational improvements
Identify, revise, and approve updates to SOPs and batch records to maintain accurate and compliant documentation
Support equipment startup and provide technical training to operations personnel
Provide technical support for process and cleaning validation activities, including cleaning cycle optimization and revalidation efforts
Ensure departmental compliance with quality, safety, cGMP, FDA, and internal regulatory requirements
Maintain technical expertise in manufacturing processes, equipment, high‑purity water systems, and utilities
Handle controlled substances in accordance with applicable state and local regulations and Johnson & Johnson requirements