Senior 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

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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 a Senior Process Specialist! This onsite position will be located in Athens Georgia.

The Senior Process Specialist is responsible for providing technical support for the Active Pharmaceutical Ingredient (API) and Monomer manufacturing processes. Technical support includes safety quality efficiency improvements and issue resolution to ensure products are manufactured compliantly and efficiently. They also support capital projects site wide initiatives or other projects as needed as a project lead or subject matter authority.

Key Responsibilities:

• Drive day-to-day manufacturing technical implementation focusing on safety quality (manufacturability) and product cost.

• Implement processes and methodologies that support the sharing of standard processes.

• Own process improvements related to safety environmental quality compliance productivity yield and cost.

• Lead multi-functional teams in the identification and performance of cost and process improvements.

• Investigate complex technical problems and provide solutions for process improvement and cost reduction.

• Own corrective/preventative measures to improve compliance and reduce repeat occurrences.

• Serve as Subject Matter Authority during internal and external regulatory audits (including FDA EMEA DEA).

• Provide documentation support for SOP/ Batch Record revisions.

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 four (4) years of relevant work experience

• Experience within Chemical Pharmaceutical Medical Device or similarly regulated manufacturing industry

• Proven 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

• Strong experience in identifying analyzing and leading process enhancements for safety quality and/or cost

• 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

• Solid understanding of Word Power Point and Excel

Preferred:

• Strong understanding of manufacturing processes process validation and continuous improvement methodologies

• 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

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 please contact us via or contact AskGS to be directed to your accommodation resource.

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