MSAT Engineer-Thermal
MSAT Engineer-Thermal
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Job Description
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
Job Function:
Supply Chain EngineeringJob Sub Function:
Process EngineeringJob Category:
Scientific/TechnologyAll Job Posting Locations:
Wilson North Carolina United States of AmericaJob 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 is expanding our manufacturing capacity with $2 billion investment to support strong portfolio growth and continue delivering breakthrough innovation and transformational medicines for patients. The new facility will expand production of innovative biologic medicines in areas including oncology immunology and neuroscience. J&Js significant supply chain investment ensures a resilient and reliable future supply of medicines to meet accelerating demand for our current portfolio of medicines and our future innovations.
The Manufacturing Science and Technology (MSAT) department manages the process technology platform strategy for the production of 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 and Life Cycle Management (LCM) of our commercial production processes.
We have a great opportunity for an MSAT Engineer- Thermal to join our MSAT Validation team ; located in Wilson NC!
Position Summary:
The MSAT Engineer will be responsible for the following:
Active engagement with the MSAT team delivering a successful outcome to all MSAT validation activities using Good Manufacturing Practices (GMP).
Primary activities are in the Thermal Validation area. Performing autoclave Cycle Development PQ and RQs execution of SIP PQs and RQs.
Leading and/or providing technical guidance for process improvement projects and investigations.
Secondary activities include but are not limited to Process Validation Support (e.g. Mixing Studies Microbial Hold Studies Media Challenges) Cleaning Validation Supporting process improvement projects Supporting New product Introduction/ process validation GMP documentation generation (e.g. protocols / SOPs / WIs / Technical Documents Exception/Event Investigations).
Key Responsibilities:
Conduct MSAT activities in compliance with US and EU regulations JBI procedures and EHS&S requirements.
Primary activities are in the Thermal Validation area. Performing autoclave Cycle Development Performance Qualifications Controlled Temperature Equipment (refrigerators/ freezers) and Re-Qualification executions.
Develop MSAT documentation (e.g. strategies plans protocols procedures reports) and co-ordinate MSAT document review and approval.
Field execution of MSAT protocols.
Liaise with Manufacturing to provide support where required with routine operations / project based work.
Compile relevant information from contractors suppliers and other departments to develop technical reports
Representing the JBI MSAT site team on platform technical teams.
Prepare reports for completed protocols for review and approval.
Initiate and implement change control activities in accordance with site procedures.
Track and resolve exceptions/events/nonconformances during MSAT activities.
Prioritize MSAT activities in line with Manufacturing / the particular project schedule.
Co-ordinate MSAT activities with contractors and vendors.
Attend identified training required to fulfill the role of a Senior MSAT Engineer.
Participate in multi-functional teams (project investigations).ired.
Review and approve documents prepared by other MSAT colleagues
Process Validation Support (e.g. Mixing Studies Microbial Hold Studies Media Challenges)
Cleaning Validation
Supporting process improvement projects
GMP documentation generation (e.g. protocols / SOPs / WIs / Technical Documents Exception/Event Investigations)
Qualifications
Education:
A minimum Bachelors Degree in Life Sciences Engineering Biology Biochemistry or related scientific field is required.
Experience and Skills:
Required:
A minimum 3 years experience in a pharmaceutical manufacturing industry or highly regulated industry
Proven knowledge and application of industry regulations including those of FDA HPRA EMEA and other authorities.
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.
Must be able to work independently with minimum supervision to meet tight deadlines
Ability to work independently under general direction having a good sense of prioritization of goals and good time management.
Preferred:
A minimum 2 years experience in biological Thermal Validation
Experience in Projects Process Validation Support (e.g. Mixing Studies Microbial Hold Studies Media Challenges) Cleaning Validation supporting process improvement projects Supporting New product Introduction/ process validation.
Thermal temp mapping knowledge
The ability to interact at different levels of the organization perform under pressure and handle conflicting interests.
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%.
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 and 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 email the Employee Health Support Center () or contact AskGS to be directed to your accommodation resource.
Employment Type
Full-Time
