Experienced Engineer Process Engineering- Thermal Validation
About The Position
Johnson & Johnson is currently seeking an Experienced Engineer - Thermal to join our Manufacturing Science and Technology team located in Wilson, NC. J&J is expanding its manufacturing capacity with a $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. 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
Requirements
- Degree in Life Sciences, Engineering, Biology, Biochemistry, or related scientific field is required.
- 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.
- At least 3 yrs experience in the pharmaceutical manufacturing industry or equivalent.
- Must be able to work independently with minimum supervision to meet tight deadlines.
- Experience in biological Thermal Validation (Minimum 2 years).
- Proven knowledge and application of industry regulations including those of FDA, HPRA, EMEA and other authorities.
Nice To Haves
- 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.
- The ability to interact at different levels of the organization, perform under pressure and handle conflicting interests.
- Ability to work independently under general direction, having a good sense of prioritization of goals and good time management.
- Ability to lead multi-functional teams and to manage complexity and change.
Responsibilities
- Conduct MSAT activities in compliance with US and EU regulations, JBI procedures and EHS&S requirements.
- 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.
- Review and approve documents prepared by other MSAT colleagues.
- 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 as required.
- Attend identified training, required to fulfill the role of a Senior MSAT Engineer.
- Participate in multi-functional teams (project, investigations) as required.
- 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).
Benefits
- Vacation –120 hours per calendar year
- Sick time - 40 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
- Holiday pay, including Floating Holidays –13 days per calendar year
- Work, Personal and Family Time - up to 40 hours per calendar year
- Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
- Condolence Leave – 30 days for an immediate family member: 5 days for an extended family member
- Caregiver Leave – 10 days
- Volunteer Leave – 4 days
- Military Spouse Time-Off – 80 hours
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What This Job Offers
Job Type
Full-time
Career Level
Senior
