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• Schedules, oversees, and performs Preventative Maintenance (PM) and Calibration on all production and facility equipment at the Grand Avenue and Wyckles Road facilities.
• Plans semi-annual maintenance shutdown scheduling and planning.
• Maintains the computerized maintenance work order system and calibration tracking system including creation and update of all PM, Work Orders and Calibration.  Ensures PMs, Work Orders and Calibration forms are issued and assigned in a timely manner.  Ensures new users are trained.
• Most of the incumbent’s time is spent finding the best solution to maintenance and instrument related problems, performing investigating because of deficiencies, and implementing corrective and preventive actions.

• Support equipment, system and facility modifications and upgrades for automated process efficiency, regulatory compliance and replacement of obsolescent equipment, controls and systems.
• Demonstrate technical knowledge to write detailed work orders / investigations related to facility equipment and systems and process equipment.
• Provide leadership and support for continuing process improvement efforts for other functional groups. This shall include the execution of projects which benefit efficiency and/or productivity, supporting project justification analysis, program preparation, project implementation, scheduling resources, and support engineering for cost tracking.

• Enhance the mechanical, electrical, and electronics skills within the department.  Provide technical resources to departments within the organization regarding facilities, controls, systems and equipment improvement based upon the departmental systems used to facilitate the workload.
• Represent and foster harmonious relationships both inter and intra-departmentally.
• Maximize software capabilities to perform job duties and analyze data for tracking and trending.
• The position also requires “Hands-on” maintenance activities to train and assist technicians.
• Interface with external organizations such trade contractors, equipment suppliers, and service providers.
• Responsible for housekeeping function, either directly or through direct reports.
• Familiar with Injectable and utility equipment maintenance, operation and troubleshooting, including but not limited to, Vial washer, Tunnel, Vial filling machine, Isolator, Capper, Vial Labeling, Inspection machine, Track and Trace, Capper, Parts washer, Autoclave, Vessels, WFI Generation & Distribution, Pure steam Generator & PW system.
• Very well equipped with SOP writing skills for Change control, CAPA, deviation and Investigation

• Routinely maintains, troubleshoots, and develops application solutions for automated electromechanical systems and software.
• Experience in a senior level position with planning, scheduling, and organizing project activities.
• Performs corrective maintenance on facility and production equipment including, but is not limited to PLCs, vision systems, SCADA system development, automated packaging equipment, and high purity utility systems.
• The incumbent may be required to work any shift and may be required to work both scheduled and unscheduled overtime.  The incumbent may be required to carry and respond to a cell phone, pager, or radio.
• Work with all departments to support the manufacturing operations and to improve methods for automated data collection and reporting, and overall reliability and performance of equipment and systems.  This includes existing systems and new installation projects.  Keep an open line of communication across departments and managerial lines.
• Familiarity and ability to use software systems for Work Orders and Calibration.  Ability to identify the appropriate materials and parts to maintain and repair equipment and order the parts using automated methods.
• Good written and verbal communication skills to interact with internal and external personnel providing timely information to avoid production delays.  This includes timely, accurate, and neat completion of documentation, such as work orders and reports that meet GMP requirements.

• Hands-on experience with implementing the (ComplianceWire) system i.e. system configuration, set-up, testing, procedures establishment, curriculum built, quizzes, and co-ordinate with the suppliers for implementing the project.
• Provides day to day administrative support of Rising’s Learning Management System (ComplianceWire).
• Set up and maintain training items, curriculums, and user groups based on feedback from area management.
• Partner with Human Resources to manually add new users to the LMS as required.
• Create, maintain, and distribute LMS reports.  Provides management with metrics and updates to assist in managing compliance with all set training objectives and requirements.
• Provide initial and refresher learner training to LMS users.  Provide advanced training to managers/supervisors on reporting functionality and curriculum maintenance process.
• Monitor online helpdesk queue and take appropriate actions to provide excellent Level 1 customer service support to LMS users via phone and screen-sharing applications.
• Assist with the development and maintenance of LMS system standards, policies, procedures, and operations manuals.
• Collaborate with instructional developers and SME trainers to ensure training content meets LMS and SCORM requirements.  Tests new and revised content to ensure activity requirements are met and content launches appropriately.
• Assist with the creation of training materials such as PowerPoint presentations, student and instructor guides, preparation for training sessions, and other related activities particularly for aseptic manufacturing and data integrity management.
• Works directly with the LMS provider to troubleshoot issues and implement bi-annual updates as necessary.
• Collaborate with business units and stakeholders in the domain to identify and incorporate all learning, enrollment, and reporting requirements into the LMS using consistent standards.
• Participate in the testing of system upgrades and functionality changes.
• Delivery of new hire and refresher GMP concept training.
• Provide support during internal and external audits related to regulatory, pre-inspection approval, and corporate compliance.
• Identifies trends and opportunities for continuous improvement of the Rising training system.

Additional Responsibilities

• Assist in other electronic data system administrative functions, as required.

• Ability to install, troubleshoot, and calibrate all types of instruments or control systems in any Rising environment.
• Maintain calibration records and enter calibration data using software such as Calibration Manager.
• Ability to use software such as MS Excel, Word, and other maintenance manager software such as AMMS to purchase items and complete validation documentation.
• Develop SOPs and change controls for new or existing equipment as required.
• Coordinate equipment calibrations for equipment to be calibrated.
• Perform calibrations in a thorough and timely manner in accordance with manufacturer’s recommendations and Rising SOPs.
• Order materials and perform instrument and control system adjustments or repairs necessary.
• to achieve compliance in advance of preventative maintenance and validation completion dates.
• Good written and verbal communication skills to interact with internal and external personnel providing timely information to avoid production delays.
• Good organizational skills to maintain a neat, clean, and orderly work environment.
• Possess and maintain competent and quick mathematical ability to perform the above job duties.
• Demonstrate a thorough and timely response to critical facility problems including environmental monitoring, security, and fire alarm parameters.
• Compliance with all OSHA and Rising safety requirements.
• Perform other duties as assigned.

• Gathering and analyzing data, blueprints, and reports.
• Determining facility and equipment specifications.
• Maintaining facility, process flow, sampling, etc. drawings to current build.
• Analyzing project costs and preparing budgets.
• Participate in the designing and overseeing the implementation of facility expansion, layout, various systems, and quality controls.
• Evaluating operational systems and facility infrastructure to ascertain and improve operational efficiencies.
• Experience in a senior level position to assist the Manager of Maintenance & Calibration with planning, scheduling, and organizing maintenance activities.
• Perform corrective and preventive maintenance on all facility equipment / systems at Rising facilities. This includes, but is not limited to mechanical, electrical, and HVAC systems.  Facility equipment includes air handlers, HEPA filtration, RO water, clean steam, WFI, boilers, compressors, pumps, chillers, and water treatment systems.
• Developing plans and optimizing internal and external resource allocation.
• Work with all departments to support the operations group by enhancing the reliability and performance of equipment at the facilities. This also includes supporting projects during installation and during validation.  Keep an open line of communication across departments and managerial lines.
• Planning and coordination infrastructure and equipment maintenance schedules and activities.
• Coordinating and overseeing contractors performing maintenance activities.
• Familiarity and ability to use software systems for Work Orders and Calibration. Ability to identify the appropriate materials and parts to maintain and repair equipment and order the parts using automated methods.
• Ensuring compliance with relevant regulations, building codes and health and safety standards.
• Preparing reports and compliance documentation.
• Good written and verbal communication skills to interact with internal and external personnel providing timely information to avoid production delays.  This includes timely, accurate, and neat completion of documentation, such as work orders and reports that meet GMP requirements.

• Schedule and plan equipment and process qualification workload to meet approved schedules.
• Handle multiple projects and work independently.
• Write, execute, and review complex protocols.
• Coordinate validation activities with other departments.
• Operate Thermal Mapping Equipment
• Able to problem solve with little oversight, including conducting research to aid in the resolution of issues that arise.
• Train other Validation personnel.
• Purchase supplies and equipment for validation activities.

Analytical Testing and Instrumentation

• Perform tests on raw materials, in-process samples, and finished products to confirm they meet specified standards.
• Utilize various analytical instruments, including HPLC, GC, UV-Vis, FTIR, and titrators, for chemical compound analysis.
• Support the development and validation of new analytical testing methods.
• Regularly calibrate and maintain analytical instruments for proper functionality.

Toxicology and Safety Analysis

• Keep the laboratory clean and organized, handling chemicals safely.
• Share test results and findings with relevant departments to aid in product enhancement.

Product Stability Testing and Shelf-Life Assessment

• Conduct stability testing on products to determine shelf life and ensure they retain quality over time.
• Analyze data to detect degradation and assess product safety and efficacy.

Data Management and Documentation

• Ensure that methods are robust, accurate, and effective for quality assurance.
• Accurately record, review, and report test results, maintaining documentation per company and regulatory standards.
• Keep detailed records in lab notebooks and electronic systems for traceability.

Regulatory Compliance and Quality Standards

• Adhere to GLP standards to ensure test results are reliable and consistent.
• Stay informed on regulatory guidelines, including GMP and FDA standards.
• Ensure lab processes are compliant to maintain certification and audit readiness

Problem-Solving and Continuous Improvement

• Identify deviations and troubleshoot issues to uphold quality standards.
• Participate in root cause analysis and investigations of any out-of-specification (OOS) or out-of-trend (OOT) results.
• Recommend corrective actions to prevent quality issues from recurring.
• Address equipment malfunctions and coordinate with maintenance teams as needed.
• Engage in continuous improvement initiatives to boost testing efficiency and quality.
• Propose improvements in testing procedures, safety protocols, and lab practices.

• Responsible for ensuring the integrity of all data and documentation reported from the Quality or R&D Laboratory
• Reviews all source data and associated documentation for accuracy and cGMP
• Reviews all source data for conformance to applicable specifications
• Facilitates data or documentation corrections with analysts to ensure all records are complete and appropriate references are made.
• Ensures Investigations are assigned to data or documentation, as appropriate prior to data verification is signed off.
• Responsible for verifying all laboratory testing was conducted in accordance with SOP’s as well as cGMP’s and GLP’s
• Review of Laboratory notebooks for completeness, and archival, as
• Interacts closely with Quality Management and all team members to identify and aid in the implementation of data security, integrity or efficiency improvements
• Understands testing and procedures within Quality
• Performs work in accordance with general and specific safety precautions
• Interacts routinely with departments such as Production, QA, RA, R&D, Validation
• Works on multiple projects in a concurrent manner on a routine
• Assist in perform Quality Assurance audits on laboratory areas to ensure cGMP compliance
• Assist in the investigation and review of deviation reports and OOS reports to assure complete compliant source data.
• Assist in training and mentoring junior analysts on the interpretation of data and use of electronic data systems.
• Demonstrate a consistent high level integrity, professional discipline and dedication to quality compliance and improvement.
• Exhibit a high level of technical aptitude and maintain an approachable demeanor to assist team members of varying capabilities and technical comprehension.
• Communicate regularly and effectively with all levels of the organization.

• Provide expertise in the review/approval of validation protocols and reports but not limited to steam sterilization, environmental monitoring, clean utilities, process equipment, temperature mappings, cleaning validation, process validation etc.
• Ensure the compliance of requalification schedule for facilities, equipment and processes based on a risk assessment, current industry “best practices,” and regulatory requirements.
• Responsible for ensuring the compliance state of Validation Master Plan Schedules, including facility, equipment, and process requalification’s.
• Excellent working knowledge of cGMP requirements on validation methods and principals including ISPE, GAMP guidelines, and FDA, CFR Part 11 Electronic Records and Signatures requirements.
• Able to mentor and train staff, and other resources as needed.
• Able to guide the validation team for developing applicable validation documentation, including, but limited to URSs, FDSs, DOEs, FATs, IQs, OQs, PQs, and VQs from scratch/manuals, if not readily available.
• Able to handle multiple, complex projects and work independently.