Sartorius Stedim, Xcellerex, Millipore, ASI, etc), Experience in equipment qualification is desired (i.e. at all times, Assist lower classification personnel and be willing to cross train as needed, Must have High School diploma or equivalent, Experience in manufacturing and assembly desired, Maintain accurate records, logs and collect necessary data, Maintain an acceptable level of attendance, High School diploma or GED, equivelant, or higher, Ability to push, pull, lift, and carry up to 20 pounds constantly, up to 50 pounds frequently and lift up to 100 pounds occasionally, At least 1 year of work experience, which required the ability to read prints, measuring tapes and calipers, Mathematical skills to read, understand, and calculate decimals, Be a consistent contributor on an evening shift, under the guidance of a shift leader, Strict adherence to current good manufacturing practices, standard operating procedures, and manufacturing documentation, Utilize knowledge to improve operational efficiency, Adhere to documented waste handling procedures to respect environmental regulations, Bachelor’s degree and 3-5 years of experience in a GMP manufacturing environment, Interested candidates must upload a resume in order to be considered. As the Companion Diagnostics Director, you will be accountable for ensuring that diagnostic tests or equivalent segmentation tools are delivered to drug products. or equivalent. Many people may question the real difference between current Good Manufacturing Process (cGMP) and Good Manufacturing Process (GMP). Sub-assemblies and final assemblies, Able to perform and verify line clearance in each work station as required, verification of the accuracy and completeness of the job/label print traveler, Work as part of the Manufacturing team to meet Production goals, Fast paced, repetitive wiring and electrical component assembly tasks of precision assemblies. To be a successful candidate for chemist jobs, resume expert Kim Isaacs says it helps to have a comprehensive resume. Manufacturing Associate Resume Examples. Experience managing represented and/or hourly employees in manufacturing, Understand manufacturing processes within a microelectronics environment, Embrace leadership and behaviors in day to day activities and execute tactically to achieve the organization’s strategic goals, Experience with selection, training, performance assessment, work assignments, salary, recognition of employees, and/or disciplinary actions, Proficient with Microsoft Office Suite software (Project Schedule, Excel, PowerPoint, Word), Basic knowledge of the Skill Certifications Training database and Property Coordinator functions, Familiar with manufacturing automation including pick and place and wire bonding, Using/Understanding PODs (Production Operation Directives), Basic knowledge of SAP, Capacity Planning and Dispatch reporting that drive business rhythm. Experience in a heavy manufacturing environment is desired, Able to read and understand written instructions, Must be accurate with both calipers and micrometer, Ability to Able to lift a minimum of 60 lbs. We work with many of the Fortune 500 and 1000 companies to provide workforce solutions. (certification a plus), Tig Welding experience a plus – minimum of 5 years proven experience preferred, Experience with both ferrous and non-ferrous metals, with strong background with 300 series stainless steels, Help train and give guidance to employees, Provide customers with the highest quality of products and services, Mounts assembled components, such as transformers, resistors, transistors, capacitors, integrated circuits, and sockets, on circuit cards and chassis assemblies, Connects component lead wires to printed circuit or routes and connects wires between individual component leads and other components, connectors, terminals, and contact points, Connects wires to wire-wrap panels according to wire lists, Assembles and attaches hardware, such as caps, clamps, knobs, and switches, to assemblies, Performs intermediate assembly tasks, such as potting, encapsulating, sanding, cleaning, epoxy bonding, curing, stamping, etching, impregnating, and color-coding parts and assemblies, Works to engineering drawing, sketches and verbal direction, works on major complex assemblies with little or no manufacturing assistances, can offer up manufacturing suggestions to improve process flow, High School Diploma and five years or more of related experience, Possession of a Bachelor’s degree from an accredited college/university according to the Council for Higher Education Accreditation (CHEA) in life sciences or a related field, or four (4) years of equivalent experience in lieu of degree, Foreign degrees must be evaluated for U.S. equivalency, A minimum of two (2) years of progressively responsible experience in GMP biotech or cell culture/fermentation, Knowledge of the regulatory issues associated with cGMP manufacturing of biopharmaceutical products, Knowledge of cGMP’s as they relate to manufacturing operations, Ability to write and follow standard operating procedures, Working knowledge of computer assisted manufacturing/production equipment, Possession of one or more skills in the following areas, Possession of a Bachelor’s degree from an accredited college/university according to the Council for Higher Education Accreditation (CHEA) in life sciences or a related field, or four (4) years equivalent experience in lieu of degree, No experience is required with a Bachelor’s degree, Four years of job related experience in a pharmaceutical cGMP environment may be substituted for the degree, This position may require work on 2nd or 3rd shift and weekends as needed, Knowledge of at least one of the following, Possession of a Bachelor’s degree from an accredited college/university according to the Council for Higher Education Accreditation (CHEA) in life sciences or a related field, or four years’ equivalent experience in lieu of degree, Foreign degrees must be evaluated for U.S. Equivalency, A minimum of two (2) years progressively responsible experience in GMP biotech or cell culture/fermentation, Performs the manufacturing process for the production of clinical and commercial Cell & Gene Therapy products, Master and Working Cell Banks, and final product fills, Demonstrates technical knowledge and contributes to the overall operations, Contributes to the achievement of departmental goals and objectives, Understands the importance of the regulatory compliance requirements for the production of biologics, Participates in manufacturing operations in assigned area per cGMPs, Authors Batch Production Records, Standard Operating Procedures (SOP’s) and Solution Preparation Records as needed to accurately reflect manufacturing processes, Completes production records and maintains clean room environment to comply with regulatory requirements, Assists in the startup and validation efforts for the Manufacturing Facility and may represent Manufacturing during Factory Acceptance Testing of new equipment, Ensures junior manufacturing personnel comply with standard operating procedures and master production records, Works on routine manufacturing assignments as well as other assignments that are complex in nature where considerable judgment and initiative are required in resolving problems and making recommendations, Normally receives no instructions on routine work and general instructions on new assignments, Works under minimal supervision from the area supervisor or area leader, High School diploma and at least 2 year experience or Bachelor’s degree, Meets physical requirements of the job, as follows: must have the ability to lift a minimum of 50 pounds, stand for long periods, bend, reach, stretch, climb ladders and work in tight spaces in order to complete job tasks, Experience in aseptic processing techniques a plus, Clarity of vision at near and mid-ranges (less than 20 feet), depth perception and ability to identify and distinguish colors, Holiday and shift work often required based on manufacturing schedule as determined by Management, Contributes to the achievement of company and departmental goals and objectives, Has a working knowledge of the regulatory compliance requirements for the production of commercially manufactured biologics, Often functions as the lead operator in manufacturing operations in assigned area per cGMPs, Ensures junior manufacturing personnel comply with Standard Operating Procedures (SOP’s) and Batch Records and that training records for junior staff are accurate and current, In conjunction with management personnel, participates in the technical transfer, planning, implementation, and maintenance of manufacturing processes and procedures, Authors Adverse Events and Reviews Validation reports and Master Production Records to ensure documents are accurate and complete, Evaluates operating procedures for accuracy and efficient operation and makes corrections as necessary, Expert on all aspects of assigned processes, Provides technical expertise to area associates and supervision during process and equipment troubleshooting exercises, Bachelor’s degree with major in Biology, Chemistry or related Science major and 4 years of experience in cell production/biologics facility or equivalent, Must have Commercial Biologics Manufacturing Experience, Ability to work under limited supervision and to handle problems of a more difficult nature, Ability to accurately and reproducibly perform arithmetic calculations including fractions, decimals and percentages and basic algebraic and geometric calculations, Must be able to wear appropriate clean room attire (i.e. Our experienced recruitment consultants will discuss your career goals and work with you to find a role that is in line with your needs. The "c" stands for "current" as a reminder that systems, processes and technologies must be kept up-to-date to comply with the latest regulations. All employment relationships at Pall Corporation - Deland are “at will.”, 3-6 years prior manufacturing experience in the pharmaceutical or biotechnology industry, with the demonstration of a high level of performance, Strong verbal and written skills. This provision does not alter or change JBT’s at will employer status, BS/BA or Associates Degree with 0-2 or more years of directly related experience. However, all candidates will be cross-trained to work in both departments, Candidates, accepted into these positions, must be willing to travel throughout United States and internationally and must possess or be able to obtain a valid passport, Candidates, accepted into the positions, will be asked to commit to work an additional four (4) years after attaining Manufacturing Technician I or Service Technician I status with JBT, subject to performance reviews and quality of work. Responsible for the timely and accurate completion of dispensing jobs as demand necessitates, Assist R&D and PD in the dispensing of new products for validation prior to new product launch, Precisely follow Manufacturing procedures, safety guidelines and quality system procedures. Current Good Manufacturing Practice (cGMP) requirements are set up by the Food and Drug Administration (FDA) and serve as the benchmark for testing the quality of drug products in order to ensure they comply with the minimum standards. plan, schedule, communication, logistics, etc.) Summary : Senior Validation Engineer with strong knowledge of Documentum, Service Now, Trackwise Change Management and Agile PLM.Strong Knowledge of Functional Risk Assessments. An Associate’s degree or Bachelor's degree is preferred, A minimum of 2 years of experience working in a manufacturing environment is required, Pharmaceutical/GMP experience is preferred, Candidates must be able to meet the physical demand of that this position requires: continuous lifting and/or moving from 5 to 25lbs. Training shall be documented." ), With Bachelor’s degree: 3-5 years of related GMP manufacturing experience required, With Associate’s degree: 5-7 years of related GMP manufacturing experience required, With high school diploma: 7-9 years of related GMP manufacturing experience required, Knowledge of cGMP manufacturing and in-depth process knowledge of cell culture processes, Thorough knowledge of laboratory and pharmaceutical production equipment including but not limited to: autoclaves, process tanks, incubators, analytical equipment and CIP/SIP systems, Proficiency in a variety of mathematical disciplines and able to work with both the metric and USA standards of measurement and military time. Must be able to put our patients at the center of everything we do, Inspired Teams environment. Autoclave, Dry Heat Oven, etc. Consistently works as a project team member on Kiazen and other improvement initiatives, Training - Can successfully train newer team members on routine processes, Continuous Improvement - Actively performs as equipment and room owner. Repetitive and electro-mechanical assembly of precision components and assemblies. Proclinical is currently recruiting for a Companion Diagnostics Expert in Gaithersburg, MD; Waltham, MA; Cambridge, UK; Gothenburg, Sweden; Shanghai, China. The FDA cGMP under 820.25 Personnel (b) Training: "Each manufacturer shall establish procedures for identifying training needs and ensure that all personnel are trained to adequately perform their assigned responsibilities. Must be able to stand for several hours. This would strengthen the resume of anyone working in an FDA-regulated manufacturing industry looking to move into management of operations or any other compliance-oriented position. Excellent knowledge of local and international Good Manufacturing Practices (GMP) and Exceptional attention to detail and competent with data entry/computer skills Approximately 3-5 years of experience in Food Safety Quality Assurance (FSQA) in industry; or … If you are searching for a new role, browse our jobs, register with us or connect on LinkedIn. Possesses strong understanding of validation concepts, Understands validation SOPs and the impact of validation on cGMPs and production, Demonstrates knowledge and understanding of GMPs and how they apply to specific responsibilities, Follows accurate verbal and written procedures in operating production equipment and performing processing steps; accurately completes appropriate production documentation, Identifies, escalates and documents events that deviate from normal operation; participate as needed in investigations, Maintains cleanliness and orderliness of operational area, Performs all operations in assigned operational area, Monitors operations to ensure compliance with process specifications, Demonstrates ability to troubleshoot basic mechanical operations, Effectively utilizes Microsoft office applications, Operate manufacturing equipment in strict accordance with SOP’s to complete task in support of cell culture operations, Perform Component Weighing, batching of media and buffer, sterile filtration and aseptic technique in a CGLP manufacturing facility, Routine production of media and buffer at 25L – 2000L scale, Perform CIP for media preparation tanks (Nalgene and stainless steel tanks), Assist in the review of document records for completeness and accuracy, Operate complex systems and equipment in strict accordance with SOP's, and safety guidelines, Operate the autoclave and perform autoclaving solutions and equipment, Assist in implementing of production procedures to optimize manufacturing processes, May participate in plant trials for evaluating process modifications, May provide training to new personnel in all areas of Media Prep and CCCD activities, Maintains all associated documentation for operations being perform, Accurately complete batch records and logs sheets, Monitor and maintain laboratory equipment operation, Requires an Associate’s degree and 3-5 years of experience or Bachelor's degree and 1-3 years of experience with cGLPs/GMPs in biotech or pharmaceutical industry and a minimum of 3-5 years’ experience with buffer, media and equipment preparation. Responsible for the quality and efficiency of equipment assigned, Completes daily production records that have been assigned to work area and/or specific operations, Adheres to SOP-s and TQM policies and procedures relating to plant specific procedures, Abides by environmental, health and safety rules established for this operation, Ensures housekeeping and health and safety standards are maintained, Complies with policies and procedures pertaining to facility or divisional adopted standards such as TS 16949 and ISO14001, Utilizes the concepts or continuous improvement and cost reduction in the execution of the job function, 1-Year of manufacturing experience preferred, Physical requirements include: prolonged standing, bending, and stooping; using both hands to push, pull, grasp and pinch; ability to lift 20 lbs. Must be extremely detail oriented, efficient and accurate in all work related to dispense and related activities, Responsible for setting up and maintaining equipment and dispensing hood as needed. Exceptional knowledgeable of current Good Manufacturing Practices (GMPs) and regulatory requirements Recommended 4+ years’ experience in a GMP biotech/pharmaceutical manufacturing environment or have a significant level of transferrable work experience to ensure the immediate support of the manufacturing team Too few trays will result in the product piling on the table resulting in down time, Ensure work area is clean and free of safety hazards, Any piece of meat that falls on the floor or any unsanitary surface must be placed on the reconditioning table or discarded, Some key behaviour's that will prevent accidents that each employee must follow are: keep your mind and eyes on the task; keep your balance; understand and discover safe working procedures; keep healthy to avoid fatigue; avoid rushing; avoid complacency; avoid frustration, Follow directions instructions at all times. 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