3 Key Consulting

Title: Engineer, GMP Physical Test Methods - Hybrid (JP13129) Location: Thousand Oaks, CA Job Description: Job Title: Engineer, GMP Physical Test Methods - Hybrid (JP13129) Location: Thousand Oaks, CA. 91320 (Hybrid) Business Unit: Employment Type: Contract Duration: 18+ months with likely extensions and/or conversion to a permanent position. Rate: $38 - $42/hour W2 Notes: Only qualified candidates need apply. Must be local to Thousand Oaks, CA will work hybrid (typically onsite about twice per week sometimes more) 3 Key Consulting is hiring! We are recruiting an Engineer, GMP Physical Test Methods for a consulting engagement with our direct client, a leading global biotechnology company. Job Description: The Engineer, in Physical Methods, is responsible for engineering activities required for the development / qualification / validation and transfer of physical GMP test methods for combination products, devices, primary containers, and secondary packaging parts. The Engineer shall have the ability to work on multiple projects at one time that may involve changes or new product, processes, tooling or equipment introduction to improve quality and reliability and reduce cost. Phases of projects include: developing combination product test methods, providing key experienced support for qualification, validation, transfer, and life cycle support of methods for manufacturing, new product introduction, training, and production support. Top Must Have Skill Sets: - Technical writing experience - Strong communication skills - CAD experience (modeling, designing) - Experience managing their own workload independently Day to Day Responsibilities: - Develop, qualify, and validate GMP physical test methods for vials, prefilled syringes, and injection devices. - Work in teams to transfer new combination product test method and assembly requirements to manufacturing, by developing six sigma processes and compiling documentation for manufacturing assembly requirements. - Develop, qualify, validate, and transfer new equipment, software, systems, and methods. - Implement projects per Final Product Technologies and company procedures to ensure projects are completed on schedule and within established budget. - Provide experienced support for investigations as well as new process development required to improve manufacturing operations. - Coordinate test method development and delivery with selected contractors. - Ensure that qualification parameters are met for product assembly requirements. - Support development of cost estimates for new processes, gauges and equipment development used in generation of capital request documentation. - Generate procedures necessary to support department and new process equipment. - Provide experienced training to individuals in the operation and maintenance of processes, test methods and equipment introduced to Quality Control and/or the manufacturing department (i.e. production operator, mechanics, process engineers). - Participate in and assume responsibilities of team functions as assigned (i.e. Product Improvement Teams). - Generate/author and be responsible for the Test Method documents. - Gather test method requirements that result in equipment that operates safely and considers ergonomic factors in the design - Perform other duties as required by the Group Manager - Align with the requirements, responsibilities, and authority as required - Maintains integrated timelines collecting appropriate multi-functional details and work which are aligned with the functional and project work - Networks internally to ensure alignment, commitment to project objectives and timelines as well as to ensure effective execution of projects - Networks with manufacturing, quality and regulatory organizations both internal and external to client - Drives the multi-functional communication and integration of information to optimize decision making, issue resolution and change management throughout project lifecycle - Excellent verbal and written communication skills are applied to communicate project status and risks associated with integrated timelines to leadership - Collaborates with other functional leaders to ensure project success, momentum and commitment - Proactively identifies issues and/or risks and develops mitigation options to resolve or increase efficiently - Integrates partner/vendor timelines with client timelines as appropriate Basic Qualifications: Master degree OR Bachelor degree and 2 years of experience OR Associate degree and 6 years of experience OR High school diploma / GED and 8 years of experience Preferred Qualifications: - M.S. in Mechanical Engineer, Chemical or Biomedical Engineering, or Chemistry - Excellent written and verbal communication skills - Ability to work in a highly matrixed team environment - 2 years of experience in the biotechnology/pharmaceutical industry - 2 years of experience in equipment, method, and mechanical design - Technical writing experience - Experience with SolidWorks (or other 3D-CAD software) - Experience with combination products and regulatory requirements - Experience applying Minitab (or other statistical software packages) Why is the Position Open? Supplement additional workload on team Interview Process: - Phone screen - Video conference We invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.

Role Description Seeking a Process Development Engineer to join the Drug Substance Technology Engineering team at our client Cambridge site. Providing strong process engineering/technology transfer support of human therapeutic drug substance products in clinical development through commercial production. Our mission is to translate developmental processes to commercial reality for patients through scientific expertise and engineering innovation. Knowledge of processes/equipment; scale-up factors, process deviations, quality attributes. GMP experience is a plus. The Engineer will apply upstream and downstream process engineering knowledge in support of technology transfer and clinical/commercial drug substance manufacturing in both stainless and single-use formats. Will partner with manufacturing, quality, analytical, and bench scientists to support a highly dynamic technology transfer. Job Responsibilities - Transfer processes for drug substance manufacturing and translate process improvements from the laboratory into manufacturing facilities. - Provide technical support for successful scale-up, transfer of process technology, and for clinical and/or commercial manufacturing operations. Experience in technical report writing is an expectation. - Assist in troubleshooting clinical and commercial runs. - Execute data trending and statistical process analysis. - Support technical direction for process-related deviations, CAPAs, and change controls. - Identify and support process-related operational excellence opportunities. - Represent process development and collaborate with other functions such as Manufacturing, Quality, and Regulatory. - Experience related to Process characterization for manufacturing of biologics is highly preferred, including technical support for authoring and review of process characterization reports. Qualifications - Master’s degree and 2 years of Engineering or Operations experience. - Bachelor’s degree and 4 years of Engineering or Operations experience. - Associate’s degree and 7 years of Engineering or Operations experience. - High school diploma / GED and 8 years of Engineering or Operations experience. Preferred Qualifications - Master’s Degree in Chemical or Biochemical Engineering. - 2+ years of Process Engineering experience preferably related to downstream/purification of commercial cGMP manufacturing facilities. - Background in biologics technology transfer into commercial facilities, new product introductions (NPIs). - Biologics purification process knowledge: Knowledge of upstream (cell culture/bioreactor operations) or purification processes (chromatography, viral filtration/inactivation, ultrafiltration/diafiltration, and final fill), equipment; scale-up factors, process deviations, quality attributes. - Strong analytical capability, troubleshooting, and problem-solving. - Independently motivated with ability to multi-task and work in teams, especially if remote or hybrid. - Excellent written and verbal communication skills with technical writing and presentation experience. Experience in PC documentation, report reviews, and technical writing preferred. Top Must Have Skills - Cell culture experience. - Purification/downstream experience. - Process characterization experience. Nice to Have - Monoclonal antibodies or mAbs manufacturing or on-floor support. Day to Day Responsibilities - Assist senior staff in technical writing, process tech transfer, data monitoring. Red Flags - No experience, not enough experience in biopharma or biotech. - No experience in cell culture/upstream, purification/downstream, or technical report writing. Interview Process - Teams interview. - Screening 30-minute Microsoft Teams interview. - Second round - Teams interview, 30 minutes each approximately with 3 other team members. Application Instructions We invite qualified candidates to send your resume to resumes@3keyconsulting.com . If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers . You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.

This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more. Role Description 3 Key Consulting is hiring an Associate Engineer, Drug Product Manufacturing Data Analysis for a consulting engagement with our direct client, a leading global biopharmaceutical company. - Remote but preferably someone who is located near Thousand Oaks or Cambridge sites for occasional onsite. - Dayshift 8AM - 5PM. - Implementation/enhancement of digital systems and automated analysis/visualization tools (Spotfire) that are utilized for streamlining data management and data monitoring. - Data extraction, verification, analysis, and technical reports for process monitoring. - Supporting investigations of adverse signals identified through process data monitoring. - Integration of new products and processes to data monitoring business process and quality management system. - Support for other ad hoc studies and projects as applicable (e.g. technology transfers of processes to new sites). Qualifications - Some industry experience through internship or research projects with a bachelor's degree. - Educational background in engineering, data sciences, biology, chemistry, or related discipline. - Drug product experience in Fill finish or inspection. - Experience with Excel, statistical process control, Spotfire, or Tableau. - Manufacturing experience; strongly preferable for this experience to be in drug product/pharmaceutical field. - Manufacturing experience in other fields may also be considered, depending on relevance of skills involved and transferability/applicability to this position. - Experience with data entry, verification, analysis, and/or data management IS systems. Requirements - Bachelor degree OR Associate degree and 4 years of experience OR High school diploma / GED and 6 years of experience. Red Flags - Lack of consistency, focus, or direction (in terms of career trajectory and interests). - Lack of clear interest in or motivation for taking on this specific role. Interview Process - Preliminary phone interview. - Team video interview. Benefits - Pay Rate: $32 - $35/hour W2. - Duration: 1+ year (with likely extensions and/or conversion to permanent).

This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more. Role Description Our ideal candidate will have 3+ years of experience in tech transfer of Biologics Drug Substance upstream and/or downstream required (Cell Culture, Harvest, Chromatography, filtration, UFDF unit ops). - Knowledge of upstream and downstream processes/equipment; scale-up factors, process deviations, quality attributes. - GMP or lab experience is a nice to have. - Strong problem solving and troubleshooting experience would be a plus. Seeking a Process Development Engineer to join the Drug Substance Technology Engineering team at our client’s Cambridge, MA. site. Providing strong process engineering/technology transfer support of human therapeutic products in clinical development through commercial production. - The Engineer will apply process engineering knowledge in support of upstream and/or downstream technology transfer and clinical/commercial drug substance manufacturing in both stainless and single-use formats. - Will partner with manufacturing, quality, analytical, and bench scientists to support a highly dynamic technology transfer. Qualifications - Master’s degree OR - Bachelor’s degree and 2 years of Engineering or Operations experience OR - Associate’s degree and 7 years of Engineering or Operations experience OR - High school diploma / GED and 8 years of Engineering or Operations experience Requirements - At least 2 years of Biologics / Drug Substance tech transfer experience required (Cell culture/ harvest/ Chromatography/ filtration/ UFDF unit ops). - At least 2 years of experience in the lab scale development work or in the manufacturing environment (pilot plant or GMP). - Strong analytical capability, troubleshooting, and problem solving skills. Interview Process - Teams screening first - Panel interviews second