Senior Process Specialist
Janssen Pharmaceuticals is recruiting for a Senior Process Specialist , located in Athens, GA!
At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us @JanssenGlobal. Janssen Pharmaceuticals, Inc. is part of the Janssen Pharmaceutical Companies.
The Sr. Process Specialist provides technical support for Oxidized Regenerated Cellulose (ORC) manufacturing processes. Technical support includes safety, quality, efficiency improvements and issue resolution to ensure products are manufactured compliantly and efficiently. Sr. Process Specialist supports capital projects, site wide initiatives, or other projects as needed as a project lead or subject matter authority.
- Drives day-to-day manufacturing technical implementation focusing on safety, quality (manufacturability) and product cost.
- Implements processes and methodologies that support the sharing of standard processes.
- Owns process improvements related to safety, environmental, quality, compliance, productivity, yield, and cost.
- Leads multi-functional teams in the identification and performance of cost and process improvements.
- Investigates complex technical problems and provides solutions for process improvement and cost reduction.
- Owns corrective/preventative measures to improve compliance and reduce repeat occurrences.
- Serves as Subject Matter Authority during internal and external regulatory audits (including FDA, EMEA, DEA).
- Provide documentation support for SOP/ Batch Record revisions.
- High school education/GED plus two years formal technical education/training or equivalent.
- 6+ years of work experience in a chemical, pharmaceutical, medical device, or similarly regulated manufacturing industry.
- Ability to lead and coordinate multiple project priorities as required.
- 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.
- Bachelor’s Degree in science preferred.
- Solid understanding of Word, Power Point, and Excel.
- Experience with SAP and Minitab.
- Experience with process control systems (e.g. Emerson DeltaV) and data historian software (e.g. OSi PI).
- Performs advanced statistical analysis of process data, including multivariate analysis.
- 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.
- Off-shift work or on-call support may be required. Must be available for other duties as required.
- Travel Requirements: up to 10% domestic/international.
- Needs to be mobile and able to independently transport themselves between various sites/locations, as instructed by the essential functions and responsibilities of the position.
Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.
For more information on how we support the whole health of our employees throughout their wellness, career, and life journey, please visit www.careers.jnj.com.