PRINCIPAL SCIENTIST Job
Johnson & Johnson
Job Code - 50507
Position - See job description
Job First Active on: Thursday, November 17, 2011
McNeil- PPC., a member of Johnson & Johnson's Family of Companies, is currently recruiting for a Principal Scientist - Metrologist, located in Fort Washington, PA.
McNeil Consumer Healthcare Division of McNEIL-PPC, Inc markets a broad range of over-the-counter products, including TYLENOL® acetaminophen products, ZYRTEC® and BENADRYL® allergy medicines, IMODIUM® A-D anti-diarrheal, MOTRIN® IB, PediaCare® upper respiratory medicines for infants and children, ROLAIDS® antacid products, ST. JOSEPH® Adult Regimen Aspirin, and SUDAFED® nasal decongestants.
The McNeil R&D laboratories Metrologist will oversee and improve all aspects of R&D laboratory calibration program including, but not limited to, laboratory equipment calibration, laboratory equipment maintenance, SOPs, and calibration standards. She/ He will develop and optimize calibration and maintenance programs, draft and execute portions of validation protocols and calibrations outlined in various protocols (IQ/OQ, PQ). The individual will negotiate and maintain qualification and calibration contracts with outside vendors and complete calibrations and maintenance activities, complete required paperwork, create procedures and troubleshoot. The Principal Scientist will work in collaboration with team members to identify trends and implement corrective actions and schedule self and contractors around laboratory activities to maintain instrument maintenance and calibration schedules needed for cGMP compliance. Further, the Metrologist will work with instrument vendors to recommend new equipment purchases to the department and complete all necessary paperwork to purchase the new instruments.
The Principal Scientist will train and mentor personnel in calibration procedures, as required and may direct the work of others and ensure the quality and compliance of the calibration/ maintenance program. She/ He will work closely with R&D Quality and Compliance to close out deviations that occur during IQ/OQ/PQ and will be responsible for developing and deploying metrics for the calibration program. The Principal Scientist will work with project teams to ensure that calibration and calibration programs are developed for new instruments will carry out all job functions in compliance with all local, state and federal regulations and guidelines including FDA, EPA, and OSHA and will comply with all company and site policies and procedures.
Under limited supervision and in accordance with all applicable federal, state and local laws/regulations, the Companies' policies, procedures and guidelines, this position will be responsible to ensure quality and compliance in all actions by attending GMP training on the schedule designated for this role and as appropriate for this role. This position must adhere to strict compliance with procedures applicable to this role; must exercise the highest level of integrity in all the tasks performed; in a timely and prompt manner, identify, report and seek correction for deviations noted in the workplace and will embrace a behavior of employee involvement and commitment to doing the job right the first time.
REQUIREMENTS - QUALIFICATIONS: PRINCIPAL SCIENTIST
A minimum of a Bachelors degree with 9 years experience OR a Masters degree with 7 years experience OR a PhD with 4 years experience is required. A degree in an Engineering field or a related discipline would be preferred. A minimum of 3 years experience in a FDA regulated environment is required. Strong professional metrology based experience is highly desired. Experience in a manufacturing or laboratory environment with analytical chemistry experience is preferred. Experience working with vendors or customers is highly desired. Experience with contract negotiations and management would be a plus. Working knowledge of cGMP's in a pharmaceutical and /or an OTC manufacturing environment is required. Experience writing calibration SOPs is required. Experience with developing maintenance program and executing calibration procedures are preferences. Knowledge of the National Institute of Standards and Technology (NIST) standards is preferred. Knowledge of GMP regulation 21 CFR parts 210 and 211 required. Knowledge of EU regulations and ISO Standards preferred. Knowledge of Microsoft Office (Word, Excel, Outlook) is required. Experience working in a LIMS system is required. The candidate must have experience leading and/or facilitating cross-functional teams. Must be detail oriented. Must have strong oral and written communication skills. Must be able to communicate effectively. Ability to adhere to all safety requirements is required. Must be willing and able to work in Fort Washington, PA BE VITAL in your career, Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
Johnson & Johnson
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