4 jobs found

SUMMARY OF POSITION :   The Laboratory Manager is a resource and go- to-person for other individuals for chemistry and Microbiology activities associated with the function performed at the Guerbet, Raleigh Location. Primary responsibilities include leading, mentoring and developing the chemistry and microbiology laboratory team which supports cGMP sterile parenteral manufacturing facility.  He/ She needs to be capable of making sound decisions to meet regulatory requirement of various agencies: FDA, EU, MHRA along with production requirements.  Make judgments on observations during review and meetings.  Have a good degree of initiative to resolve problems, discuss and research action to be taken before finalizing a resolution.   ESSENTIAL FUNCTIONS : “Working Manager” position with direct supervision of Chemistry and Microbiology laboratories.   Provide overall direction, activities and function as the authority and expert on chemistry and microbiology strategy, procedures and techniques and regulatory compliance. Active leader and decision maker on internal project related to formulation, filling, environmental, facility improvements and developing new approach to business. Strong leadership skills, the ability to prioritize, multitask and work efficiently in a dynamic, ever changing manufacturing environment. Manage the laboratory (chemistry and microbiology) department which is composed of laboratory technicians, senior and junior scientist who support the production of TS filling, formulation functions, and environmental monitoring.  Support data integrity through data review and investigations; coordinated and assign responsibilities. Perform administrative duties associated with managing a department and staff.  (i.e.  establish group goals, and reviews) Strong mentoring skills and a track record of developing subordinates Identify quality issues, and in conjunction with site Quality Manager, recommend and implements corrective and preventative actions. Knowledge of cGMP, GLP, GXP, FDA, ICH, EU and 21 CFR 11 regulations, guidelines, body policies and procedures. MINIMUM REQUIREMENTS :  Education required/ preferred: BA/BS in chemistry, biology, microbiology and/ or life sciences Experience: Minimum 8 years pharmaceutical experience/laboratory management and/or related pharmaceutical experience. Previous management level experience. Preferred Skills/Qualifications: Thorough knowledge of cGMPs and pharmaceutical manufacturing requirements. Demonstrated auditing and corrective action proficiency. Demonstrated record of successfully assessing and determining the impact of current and potential regulatory compliance issues. Demonstrated proficiency of root cause analysis as applied in a pharmaceutical manufacturing environment.  Excellent problem solving and decision making skills.  Ability to manage and drive change Six Sigma Greenbelt certification Supervisory skills Computer skills Knowledge of document management/quality systems  

SUMMARY OF POSITION :  Under the general supervision of the Engineering Manager, this position is responsible for the initiation, research, management and implementation of assigned projects, both capital and expense, for all categories of spending.  As a Project / Senior Project Engineer, this position is also responsible for the tracking of the spending forecast for all assigned Capital Projects. The Project / Senior Project Engineer is a member of the Engineering team.  As such, this position actively participates as a team member / leader on assigned plant projects and provides technical guidance to other team members on a variety of project related activities. The ideal candidate should be a motivated, self-starter who can manage multiple tasks and priorities within a fast paced environment.   ESSENTIAL FUNCTIONS :   Management and integration of new processes and equipment into the Raleigh, NC facility, including production and utility equipment. Prepares engineering proposals, feasibility studies, cost studies, and provides technical support. Utilize engineering expertise to develop clear, concise conceptions, methods, layouts and documentation to determine project feasibility.  Utilize Gantt charts to maintain control of the project timeline, budget tracking tools and progress reports to manage and communicate status on a regular basis to Project Manager and others as directed.  Responsible for closing the project in a timely manner. Work with designers, mechanics, technicians, and outside contracting firms to bring projects from the design stage to production and complete the project within time and budgetary constraints. Assist in the development and management of the site’s Capital Plan.  Track and report actual spending vs. monthly forecast. Provide capital project oversight, internal and external team coordination, cost and schedule reporting, drawing reviews, construction quality oversight, proactive change order management and administration. Work with the internal project teams to develop, maintain, and align an accurate, integrated project timeline, resource plan, and budget. Generate analyses of timelines, resources, and budget information that facilitate scenario planning, contingency planning, risk assessment/management, problem solving, and decision-making. MINIMUM REQUIREMENTS :  Education required/ preferred:  Bachelor’s Degree in Engineering (required). Professional Engineer Registration (preferred).  Experience: Minimum 5 years of industrial experience in a regulated environment (food, beverage, or pharmaceutical). Minimum 2 years of project management experience in a regulated environment (food, beverage, or pharmaceutical). Project management, cost estimation, and project scheduling experience.   Preferred Skills/Qualifications: Background in managing Lean/Six Sigma projects and initiatives.

SUMMARY OF POSITION :  The Formulation Technician is responsible for all aspects of integrating formulations into the production environment. This includes monitoring current processes, adapting new processes, and ensuring regulatory compliance.    ESSENTIAL FUNCTIONS :  Adapt formulations processes to production environment  Prepare/review process documentation  Formulate existing products  Formulate Complexation Products  Train operations personnel on new/existing processes  Primary trainer for complexation product line  Identify and implement improvements for existing processes  Write and revise standard operating procedures, preventative maintenance work orders  Executing CAPA, OOS, and Change Control Action items  Complete full investigation utilizing root cause analysis tool such as 6Ms, KT analysis, 5 Whys, etc.   Ensure compliance with all regulatory agencies  MINIMUM REQUIREMENTS:  Education required/preferred:         Science or Engineering Degree preferred Experience:                                                           0-2 experience in a pharmaceutical manufacturing   Preferred Skills/Qualifications:                     Must have excellent verbal and written communication skills      Must have good interpersonal skills    Mechanical aptitude required   Willingness to work flexible hours which includes overtime/off-shift work   Skills/Competencies:                                      Ability to interact with R&D, Quality Control, and Quality Assurance personnel               Ability to use HMIs, Touchscreens, barcode systems, and  desktop computer programs   Other Skills:                                                   Read – Standard Operating Procedures and training Material and  follow procedures            Write – Fill our paperwork as required   Basic Math Skills – Ability to ask questions and express  concerns and ideas logically   Good Manufacturing Practice Knowledge   

SUMMARY OF POSITION :  Administrator of BlueCielo Meridian Drawing Vault, Autodesk AutoCad and associated drawing files.  ESSENTIAL FUNCTIONS :  Create manual and electronic drawings, using Autodesk AutoCad for electronic drawings. Maintain security of master drawings & files (physical and electronic versions). Perform field checks of drawings as needed. Administer and maintain drawing database (BlueCielo Meridian Drawing Vault). Assist in the execution / maintenance of change requests for Plant operations and projects. CAD As-Built drawings from redlines provided by internal and external sources. Maintain secure and accurate drawings for the entire production site and all processes. Maintain the retention schedule of plant drawings (physical and electronic versions). MINIMUM REQUIREMENTS :  Education required/ preferred: High School Diploma, GED, or Equivalent (required) Technical School degree (preferred) Experience: 3-5 years Preferred Skills/Qualifications: Strong computer skills with proficiency in the following:  BlueCielo Meridian Drawing Vault and Autodesk AutoCad. Skills/Competencies: Microsoft Excel, Access, Powerpoint and Word Other Skills: Excellent communication skills