Associate Manufacturing Process Specialist

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at .

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.

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About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments finding cures and pioneering the path from lab to life while championing patients every step of the way. Learn more at 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 this role youll work alongside dedicated colleagues who care deeply about doing whats 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.

KEY RESPONSIBILITIES:

• Provide primary onfloor 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 nonconformances investigations and rootcause 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 highpurity water systems and utilities

• Handle controlled substances in accordance with applicable state and local regulations and Johnson & Johnson requirements

QUALIFICATIONS:

EDUCATION:

• Minimum of a High School Diploma or equivalent diploma/degree required; Associates Trade/Technical Vocational Bachelors or equivalent degree/diploma/certification strongly preferred

EXPERIENCE AND SKILLS:

Required:

• 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

Preferred:

• 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)

OTHER:

• 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

#LI-Onsite

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity age national origin disability protected veteran status or other characteristics protected by federal state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants needs. If you are an individual with a disability and would like to request an accommodation external applicants please contact us via internal employees contact AskGS to be directed to your accommodation resource.

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