Senior Process Specialist

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

Job Function:

Supply Chain Engineering

Job Sub Function:

Process Engineering

Job Category:

Scientific/Technology

All Job Posting Locations:

Athens, Georgia, United States of America

Job Description:

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 https://www.jnj.com/innovative-medicine

We 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; Associate's, Trade/Technical, Vocational, Bachelor's, 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 regulator