Sr Process Engineering- MSAT

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 today for this exciting opportunity to be part of our growing team!

The Manufacturing Science and Technology (MSAT) department manages the process technology platform strategy to produce biotherapeutics in the new BioProcessing Facility in Wilson North Carolina. We are responsible for Process Thermal & Cleaning Validation Standardization of Equipment for New Product Introduction Process Analytics Introduction and Life Cycle Management (LCM) of our commercial production processes.

We have a great opportunity for an MSAT Tech Transfer Engineer to join our MSAT LCM & Process Analytics team located in Wilson NC!

Key Responsibilities:

• Active engagement with the MSAT team delivering a successful outcome to MSAT Tech transfer activities and Process Analytics implementation using Good Manufacturing Practices (GMP).

• Primary activities are in the Tech transfer of new/commercial products as well as implementation of new technologies and/or digital tools. Planning documenting and performing process validation studies.

• Coordinate and execute MSAT process lifecycle management activities for new equipment processes and site startup initiatives in compliance with US and EU regulations and company procedures.

• Coordinate and execute process improvement projects commercial product scale-up initiatives and technical transfer activities ensuring a successful implementation.

• Apply technical expertise to offer second-line support to our Manufacturing Operations team as well as provide technical guidance for process improvement projects and investigations.

• Track and resolve exceptions/events/nonconformances during MSAT activities.

• Coordinate and prioritize MSAT activities in alignment with the applicable manufacturing and project schedules.

• Implement qualify and maintain PAT tools (e.g. Raman spectroscopy capacitance probes soft sensors) to enable realtime monitoring of upstream and downstream CQAs and CPPs.

• Integrate PAT instrumentation with manufacturing data systems to support process control process robustness and continuous verification as well as analyze process data to identify trends deviations and sources of variability across biologics manufacturing operations.

• Conduct statistical modeling multivariate analysis (e.g. PCA/PLS) and batch trajectory analytics to support investigations CPV continuous improvement initiatives and detect early signals of process drift.

• Support model lifecycle activities including development validation documentation and ongoing performance monitoring in a GMP environment.

• Able to author basic modeling-related documents (e.g. model development reports analysis summaries).

• Prepare review and approve technical documents CAPAs change control requests investigations protocols reports and SOPs as needed.

• Compile relevant information from contractors suppliers and other departments to develop technical reports.

• Attend identified training required to fulfill the role of a Tech Transfer Engineer.

• Participate in multi-functional teams (project investigations) as required.

Qualifications

Education:

• A minimum bachelors degree in Life Sciences Engineering Biology Biochemistry or related scientific field required.

Experience and Skills:

Required:

• A minimum of 7 years of experience in the pharmaceutical manufacturing industry or regulated industry experience or 4 years with advanced degree (MS/MBA/Ph.D or equivalent).

• A minimum 2 years of experience in Technical Transfer process.

• Experience with process analytics modeling.

• Proven knowledge and application of industry regulations including those of FDA EMEA and other authorities.

• Ability to collect process and analyze data to draw meaningful conclusions and make informed decisions for studies

• Excellent verbal and written communication skills including ability to effectively communicate with internal and external customers.

• Excellent computer proficiency e.g MS Office Excel SAP.

• Ability to interact at different levels of the organization perform under pressure and handle conflicting interests.

• Adaptable and flexible with great problem-solving skills.

• Ability to work independently with minimum supervision having a good sense of prioritization of goals and good time management.

Preferred:

• Supporting New Product Introduction/ process validation.

• Ability to lead multi-functional teams and to manage complexity and change.

Other:

• This role may require periods of increased travel to support startup activities based on functional needs and project some cases this could involve frequent travel and/or short-term stays with vendors sister companies or steady state we expect travel to be <10%.

For more information on how we support the whole health of our employees throughout their wellness career and life journey please visit .

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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