MSAT Engineer-Thermal

s the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://https://www.jnj.com

Job Function:
Supply Chain Engineering
Job Sub Function:
Process Engineering
Job Category:
Scientific/Technology
All Job Posting Locations:
Wilson, North Carolina, 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://https://www.jnj.com/innovative-medicine.

J&J 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&J's 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 RQ's, 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 timelines. In some cases, this could involve frequent travel and/or short-term stays with vendors, sister companies, or partners. In 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 ([email protected]) or contact AskGS to be directed to your accommodation resource.

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

J&J 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&J's 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 RQ's, 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 timelines. In some cases, this could involve frequent travel and/or short-term stays with vendors, sister companies, or partners. In 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 ([email protected]) or contact AskGS to be directed to your accommodation resource.