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Job Summary
Manufacturing Science and Technology (MSAT) 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 & Cleaning Validation, Standardization of Equipment for New Product Introduction, and Life Cycle Management (LCM) of our commercial production processes.
Essential Job Duties and Responsibilities
We have a great opportunity for a MSAT Experienced Engineer to join our Thermal Validation team.
The experienced MSAT Engineer will be responsible for the following: 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
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.
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).
Minimum Qualification
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.
Other requirements
Experience in biological Thermal Validation (Minimum 2 years).
Excellent verbal and written communication skills, including ability to effectively communicate with internal and external customers.
Also, beneficial would be 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.
Proven knowledge and application of industry regulations including those of FDA, HPRA, EMEA and other authorities.
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 (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource.
Required Skills
Preferred Skills
Analytical Reasoning, Computerized Equipment Skills, Emerging Technologies, Gemba Kaizen, Issue Escalation, Lean Supply Chain Management, Problem Solving, Process Control, Process Engineering, Process Oriented, Product Improvements, Science, Technology, Engineering, and Math (STEM) Application, Situational Awareness, Supply Planning, Technical Research, Technologically Savvy, Validation Testing
The anticipated base pay range for this position is
79,000-120,000
Additional Description for Pay Transparency
Subject to the terms of their respective policies and date of hire, Employees are eligible for the following time off 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 Additional information can be found through the link below. https://www.careers.jnj.com/employee-benefits
