Operations Specialist supporting shop floor execution, batch closeout, and troubleshooting in a GMP manufacturing environment.
Compensation
The salary range for the primary location of this role is: $79,200.00 - $124,700.00. The successful candidate will be eligible for annual bonus and long‑term incentive, if applicable.
Responsibilities
Partnering with the Operations management team to create and execute strategies that support design, development, delivery and evaluation of projects related to steady‑state production and/or continual process improvement.
Authoring and reviewing documents and SOPs.
Batch Record Review.
eLog Review.
Lead safety investigations.
Requirements
High School Diploma
Bachelor’s degree in a technical field
Bachelor's degree in a direct GMP, biotechnology, manufacturing setting
Nice to have: Understanding of MPS methodologies
Nice to have: Experience with shop‑floor cGMP manufacturing and related systems (i.e. SAP)
The Reliability Engineer improves the reliability, maintainability, safety, and lifecycle performance of cGMP and non-cGMP manufacturing, utility, facility, and process systems using asset-performance data, risk assessments, and predictive technologies.
Compensation
The salary range for this position is: $100,500.00 - $145,166.66
Responsibilities
Analyze CMMS/EAM data, downtime, deviations, work orders, maintenance costs, condition-monitoring results, spare-parts usage, and equipment history.
Senior Quality Assurance Associate responsible for quality assurance in Pfizer’s Quality Risk Management program at the McPherson site.
Compensation
The annual base salary for this position ranges from $82,700.00 to $137,900.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 10.0% of the base salary.
Responsibilities
Responsible for SME strategic review and evaluation of quality risk assessments and potential risks that impact the McPherson plant
Monitors quality system metrics and executes actions to ensure quality system performance
Provide support and act as liaison to business units, corporate, and stakeholders for quality risk management process
Serve as the McPherson site resource for quality risk management
Acts as quality authority for quality risk management
Using standard operating procedures (SOP) and good manufacturing practices (GMP), the Engineer/Scientist I will perform testing of intermediate and raw materials. The Engineer/Scientist I will be responsible for all aspects of laboratory testing, such as sample receipt, data generation, product verification, data analysis and summarization, instrument operation, and other QC lab supporting activities.
Compensation
Pay Rate: $30/hr on W2
Responsibilities
Conducts analytical and functional testing of raw materials and intermediates according to approved SOPs as part of QC Raw Material testing.
Perform testing using chemistry clinical analyzers and document test results accurately using Excel spreadsheets and workbooks.
Documents test results, complete batch records, document problems and other relevant information under cGMPs.
Perform simple revisions and updates to QCs SOPs and/or worksheets as necessary, and initiate procedure change orders.
Summarize test data, maintain lot histories and evaluate data for trends and discrepancies.
Requirements
Bachelor's in Chemistry
Bachelor's in Biochemistry
Bachelor's in Bioscience
Nice to have: cGMP understanding
Nice to have: intermediate word processing and spreadsheet software skills
Responsible for providing technical support to operations in terms of equipment/system initial validation and equipment/system requalification’s.
Compensation
Salary Range: $60,966 -$85,694
Responsibilities
Drafts protocols and executes equipment commissioning, qualification, and requalification’s per Standard Operating Procedures (SOPs). Coordinates and communicates all testing with affected functional groups and evaluates test results.
Analyzes data, composes a final report and circulates for approval.
Executes equipment validation studies to include protocol preparation, scheduling, protocol execution, and final report preparation.
Participates in presentation of results to Regulatory Agency when necessary.
Programs and operates department analytical instruments (such as temperature/humidity dataloggers) to perform controlled temperature/humidity chamber qualifications (examples lyophilizers, warehouses, sterilizers, incubators, etc.).
Responsible for cleaning, loading commodities, startup activities, and operating the batch in a cleanroom environment while following SOPs and cGMP.
Compensation
Hourly Range: $13.61 - $20.05
Responsibilities
Cleaning, loading all the commodities, startup activities, and the normal operation of the batch.
May perform minor maintenance and preventative maintenance of production lines.
Use of cleanroom behavior technique while in the classified areas to minimize potential for product contamination.
Learning to master the set-up of the filling equipment and operate and perform minor mechanical troubleshooting of a fully Integrated Bag Making Filling Machine (IBFM), Robot Cell Overwrap equipment (RCO) and Overwrap Machine, in a cleanroom environment, to ensure minimal downtime is encountered.
Perform peer to peer batch record documentation review throughout the shift to ensure documentation is accurate and in alignment to the Good Documentation Practice standards.
The role of a Maintenance Supervisor is to provide the necessary guidance, knowledge, and skill sets needed to properly and efficiently maintain, troubleshoot and repair Fresenius Kabi process equipment and utilities.
Compensation
Salary Range: $80 to 100K
Responsibilities
Lead, coordinate and oversee routine and non‑routine maintenance/repairs and daily operations of process manufacturing equipment and utilities
Apply mechanical, electrical and controls knowledge to assess problems, identify root cause and perform repairs
Coordinate maintenance activities with master production schedule and manufacturing personnel
Establish and maintain preventive maintenance procedures and schedules
Identify and maintain critical spare parts inventory
Requirements
Bachelor’s Degree in Engineering field or equivalent relevant work experience
Senior scientist providing technical support for commercial and pilot laboratory operations at Elwood, Kansas monoclonal antibody manufacturing facility.
Responsibilities
Partner with Manufacturing, Development, and Quality teams to execute technical and development studies, investigations, validation activities, and technical transfer programs.
Collaborate with cross-functional teams to identify risks, sources of variability, improvement opportunities, and value engineering opportunities to maximize project return and technical success.
Apply scientific and statistical analysis tools to improve process understanding, ensure manufacturing processes remain capable and in a state of control, and identify opportunities for process improvement.
Participate in the design, development, execution, commissioning, qualification, and validation of major projects.
Support project scope definition, development and analysis of design options, establishment of user requirements, equipment selection, and commissioning and qualification activities.
Requirements
Bachelor’s degree in Bio/Pharmaceutical Technology, Microbiology, Engineering, or a related discipline
Nice to have: MSc or PhD in Bio/Pharmaceutical Technology, Microbiology, Engineering, or a related discipline
Nice to have: 5+ years in Biotechnology or Pharmaceutical industry
Nice to have: Experience with commercial monoclonal antibody or recombinant protein manufacturing processes
Support all aspects of central and satellite warehousing requirements for the site regarding the General Ambient, Hazardous, Cold & Frozen Storage and Manufacturing Storage (Fermentation, Recovery, Purification) functioning as part of a high-performance work team.
Responsibilities
Support material handling operations for hazardous, ambient, +5c and -20c materials in drum, pallet and IBC configurations, using desktop and RFT (scan gun) transactions in SAP for receiving, labeling, storing, retrieving, shipping and delivery
Fulfil production order requirements including Kanban area replenishment
Assist in monitoring inventory control of all warehouse materials including physical inventory of EJ Warehouse, Spine Warehouse and assigned production track areas through storing, retrieving, cycle counts and year-end inventory of materials
Develop system knowledge in SAP/ERP, MES, Coupa, Coldstream, Robex, Tulip, NNTZW, K&N 4PL to be able to utilize system transactions to perform receipt, issuance material transfer, production intermediate batch staging and shipping
Develop knowledge of inventory control of all incoming, intermediate and shipping of materials to support site manufacturing goals
Requirements
High School Diploma (GED)
Associate’s Degree in Tech, Science, Supply Chain, Logistics or Engineering
Logistics Associate INewNovo Nordisk A/S · Clayton, US