Job Information
J&J Family of Companies MSAT Large Molecule Scientist in Gurabo, Puerto Rico
MSAT Large Molecule Scientist - 2406191186W
Description
Johnson and Johnson is seeking for a MSAT Large Molecule Scientist to join our TEAM located in Gurabo, PR!
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through 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 humanity. Learn more at https://www.jnj.com/.
For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world’s most pressing healthcare challenges. We know that the success of our business – and our ability to deliver meaningful solutions – depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued, and our people can reach their potential.
At Johnson & Johnson, we all belong.
Are you interested in joining a diverse team delivering outstanding results to our patients through our Innovative Medicine products? Apply now for this exciting role!
The MSAT LM Scientist is responsible for giving continuous support to the following validation programs: Production Equipment (moist heat / depyrogenation), Filter Qualification, Cleaning validation, Processes validation, Qualifications, Packaging, and Aseptic Process Simulation (APS). The incumbent is also responsible for the feasibility, assessment and execution of the different project steps and coordinating activities with the different units of the Janssen Cilag Manufacturing, LLC organization, as the need arises. This position enables the company to be aligned with the current regulatory requirements of the pharmaceutical industry.
Key Responsibilities:
Lead and execute process, cleaning, sterilization process, machine-abilities, lyophilization cycle validations, Packaging validation and APS studies.
Search for literature to understand the systems, equipment and processes presently used in our GMP related operations.
Develop validation protocols based on available literature, company procedures, guidelines, and applicable regulations.
Coordinate with other departments and execute all the activities vital for the validation program.
Compile, review and analyze validation data and summarizes results and conclusions in technical reports.
Preparation of Technical Reports (RPT’s) to document technical activities in support of regulatory compliance and submissions.
Design of studies and preparation of protocols to evaluate alternate components and raw materials, alternate methods of manufacture, process and product anomalies, cost savings opportunities, and process, equipment, and cleaning validation.
Provide technical support to investigations and resolution of process deviations.
Initiate Change Controls and complete technical / validation assessments to changes owned by other functional groups.
Provide technical expertise on procedures and Validation Master Plan revisions. Provides technical training in technical areas such as: qualification, validation, technical transfer, and new process implementation.
Special Project execution / coordination.
Participate and provide technical expertise in the critical review of all document associate with the manufacturing of sterile products.
Lead aseptic processing special projects to accomplish company goals and objective on the timely and effective manner.
Collaborate directly with manufacturing operations to ensure that appropriate environmental and aseptic procedures are in place, through the execution of comprehensive reviews of procedures against practice.
Work with other teams to address technical issues and resolve them using sound scientific reasoning and technical expertise. Provides guidance to the team on technical issues.
Identify areas of process improvements. Works with technical groups to implement process improvements. May lead process improvements initiatives depending on complexity.
Participate in audits. Supports regulatory agency interactions.
Qualifications
Education:
- A Bachelor's Degree in Chemistry, Pharmacy, Biochemistry, Chemical Engineering or related Science or Engineering is required.
Experience and Skills:
Required:
A minimum 4 years of relevant work experience
Knowledge of cGMP's, FDA regulations, and pharmaceutical manufacturing equipment
Must have knowledge of aseptic manufacturing process
Experience in a Technical support or Manufacturing environment in the pharmaceutical / medical device or similar industry
Knowledge on Technical support, computer literature, collaboration
Able to work in a manufacturing environment of Parenteral
Proficiency in the use of MS Office applications: Word, Excel, Power Point
Must be fluent in Spanish and English and have excellent writing and good communication skills
Works effectively and collaboratively with a broad cross section of functional areas
Ability to work with moderate supervision and make appropriate decisions
Excellent team skills in a multi-cultural environment
Knowledge of pharmaceutical validation / qualification
Ability to work several tasks at the same time. Interpersonal skills. Establishment of Priorities
Able to work under time pressure, validated leadership skills
Ability to work with strict deadlines with sense of urgency
Strong communication and excellent presentation skills
Work with precision
Preferred:
Knowledge of MCA & Japan regulations, lyophilization technology, utilities and environmental controlled areas, packaging, process, and cleaning validation.
Critical thinker, ability for problem solving, knowledge of basic statistical tools
Technical knowledge in pharmaceutics / formulation process
Knowledge of Process Critical Parameters. Optimization of production processes
Ability to manage multiple priorities
Experience in defining problems, collecting data, establishing facts, and draw valid conclusions
Ability to calculate numbers and quantities and work with proportions percentages
Experience and/or knowledge to read, interpret, and analyze documents such as technical reports, risk assessments, procedures, Master Batch records and other complex documents
Work in teams and independently
Ability to follow and interprets a wide range of instructions in technical and mathematical form
Solid decision making skills
Other:
Requires up to 10% domestic and international travel
Requires to carry less than 10 pounds occasionally.
Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com .
Primary Location NA-US-Puerto Rico-Gurabo
Organization Janssen - Cilag Mfg LLC (8427)
Travel Yes, 10 % of the Time
Job Function Product Safety Risk Management
Req ID: 2406191186W