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Technical Services Manager - Site Master Plan-8254130305
McNeil Healthcare, LLC, a member of Johnson & Johnson's Family of Companies, is recruiting a Technical Services Manager - Site Master Plan for the facility located in Las Piedras, Puerto Rico.
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, MOTRIN® IB, PediaCare® upper respiratory medicines for infants and children, ROLAIDS® antacid products, ST. JOSEPH® Adult Regimen Aspirin, and SUDAFED® nasal decongestants. McNeil-PPC, Inc. entered into a consent decree, or agreement, with the agency that governs certain manufacturing operations to help ensure quality and compliance. Now is an exciting time to join our business, as we focus on reaffirming the integrity of our iconic brands that are staples of households worldwide. Whether you view this opportunity as a potential career accelerator here, within the J&J's Family of Companies or beyond, or whether this is your entry to the J&J's Family of Companies, we invite you to join us…. Creating the future of McNeil.
The selected candidate will be responsible of managing all activities related to the Commissioning, Qualification, Process Development/optimization, Process Validation and cleaning validation, related to the Site Master Plan. Review and evaluate the required/generated documentation to execute Validations and Qualifications including: Validation Master Plan, Validation and Qualification Protocols, Validation Packages and Qualification of Data. Coordinate and supervise all related activities including time and events schedule, equipment/personnel requirements and personnel training. Manages Qualification and Validation scope, schedule and budget for the Las Piedras Site Master Plan. Provide support and technical assistance to the manufacturing units during internal/external audits or investigations. Develop action plans for the transfer of new technology, products and/or processes related to the expansion and/or upgraded manufacturing areas. Will also attend GMP training on the schedule designated for the role and as appropriate for the role. Adhere to strict compliance with procedures applicable to the role. Exercise the highest level of integrity in the tasks that he/she performs. In a timely and prompt manner, identify report and seek correction for deviations noted in the workplace. Embrace a behavior of employee involvement and commitment to doing the job right the first time. Ensure employees under his/her scope of responsibility are trained in required procedures for the execution of their role and maintain current with training requirements during the year. Promote an environment of employee involvement in the workplace. Seek prompt identification, reporting and correction of deviations in the workplace as noted by employees. Assures job descriptions are discussed with employees within the first five days of hiring, when the job descriptions have been revised or as needed, and submits the attendance sheet to the administrative assistant/coordinator of the area for processing. (Applicable only to the supervisory level). Assures trainings in the assigned tasks have been delivered prior to execution. Complies with the safety and environmental trainings, policies and procedures. Acts in accordance to the principles expressed in Our Credo and the Quality Statement in all negotiations and activities within and outside the company, and assures these are met. Coordinates and supervises all activities related to the Validation, Process Optimization and Qualification executed by the Technical Services and Validation department, manufacturing groups, process support groups and external contractors including: time and events schedule, equipment/personnel requirements and personnel training. Reviews and evaluates the required/generated documentation to execute Validations and Qualifications including: Validation Master Plan, Validation & Qualification Protocols, Validation Packages and Qualification of Data. Revise and change proposed or executed modifications to validate systems. Prepares periodic status reports related to department projects. Makes recommendations as required. Provides technical assistance to production/manufacturing units and during external/internal audits or investigations. Defines the needs of department personnel and equipment (long and short term). Implements and provides follow up to projects (technical studies of Validation and/or Qualification) required by senior management. Develops department Business Plan based on the general objectives of the Company. Supports J&J Corporate audits and FDA audits by providing his/her technical expertise. Prepares and administers department budget. Develops action plans for the transfer of new technology, products and/or processes to the Company. Develops action plans for the transfer of new technology, products and/or processes to the Company. Provides technical assistance to units of production/manufacturing during the course of complex investigations. Reviews and evaluates the documentation required/generated to execute process optimizations. Provides technical assistance to the R&D unit during the transfer of new products to Las Piedras. Supervises technicians, documentation coordinator, scientists and Coop students of the Technical Services department. Coordinates revision activities of operational procedures, equipment use/cleaning logbooks, and administrative forms to support the Manufacturing areas.
A minimum of a Bachelor's Degree in Science or Engineering is required. Registered Pharmacist, Chemistry, Chemical or Mechanical Engineering is highly preferred. Rph, PE and/or PMP certifications/licenses are preferable. Must have ten (10) years of working experience in process and cleaning validation, technology transfer and commissioning/qualification within the pharmaceutical manufacturing of solid dosage environment. At least five (5) years of experience working at a management level. Experience managing projects is required. Fully Bilingual (English and Spanish) is required. Must be knowledgeable in cGMP's and pharmaceutical industry applicable regulations. Computer knowledge in Microsoft Office applications (Word, Excel, PowerPoint, Outlook & MS Project) is required. Should have knowledge of a statistic program. Must be available to travel in and outside of Puerto Rico and to work extra hours and to respond to emergency calls that require returning to the company after regular working hours of the business. Must be able to support other departments and/or projects according to business needs.
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Primary Location: North America-United States-Puerto Rico-Las Piedras
Organization: McNeil Healthcare LLC (7598)
Job Function: Validation
Johnson & Johnson Family of Companies - 21 months ago
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