Validation Engineer- Chelsea, MI
These resources will begin by reviewing validations that have been done over the past three years and identifying gaps, focusing upon, among other things, appropriateness of sample sizes and statistical rationales. After identifying gaps and identifying remediation’s, they will rewrite the protocols, educate those performing executions on some of the problems that may arise and how to address them, then oversee the executions, gather the master data, and write the final reports.
Equipment and Process Validation a MUST
Equipment will include, but not be limited to, CNC mills, mills, asd laser marking equipment. Processes will be customer-specific molding processes, primarily injection molding a MUST.
Equipment Engineer – Salt Lake City, Utah
Analyzes and develops solutions to engineering problems related to manufacturing equipment and systems or the causes of component failures. Develops and applies engineering standards and procedures and provides advice on issues within the engineering field.
This is an individual contributor role that requires the use of judgement in applying professional expertise and is expected to work independently with minimal supervision.
Bachelor’s degree in mechanical, electrical, or mechatronics engineering from an accredited university. Four years of engineering experience with responsibility for manufacturing support, or process design. Two of the four years additionally include equipment engineering responsibilities for specifying, designing, qualifying, or troubleshooting equipment to support product/process development or manufacturing operations.
• Ability to analyze, troubleshoot and resolve issues relating to the safety, ergonomics, and efficacy of equipment, tooling, and fixtures.
• Ability to identify equipment, fixture, service, design and fabrication suppliers; assess supplier capability and recommend their use.
• Ability to specify requirements and execute factory and site acceptance testing (FAT/SAT) for custom or off-the-shelf purchased equipment.
• Ability to create equipment specifications and define requirements for the installation (IQ) and operational qualification (OQE) of equipment, tooling, and fixtures.
• Ability to perform duties in compliance with a site quality management system that is governed by the US Code of Federal Regulations, Title 21 and European MDD.
Process Engineer- Tempe, AZ
The Senior Process Engineer will be responsible for assuming the role of technical & business lead on new product and process introductions. Will be responsible to ensure complete Production facility preparation of the new product & process. Ensures that all technical and business-related demands such as building, facilities, utilities, machine & equipment capacity, hiring, procedure writing, training, verifying & validating, protocol & report writing, problem solving, demand planning and performance metrics are successfully executed and achieved. Serve as the voice of operations between the development site and manufacturing site during the new product/process development process
- Prepare the manufacturing facility, and coordinate the transfer, for the full-scale implementation of new products/processes to the production floor.
- Provides on-going status reports and observations to management and key stakeholders.
- Reports problems clearly and concisely, recognizing and highlighting specific deviation.
- Operate within Stryker’s quality system to produce documentation such as process validations, equipment qualifications, dynamic control plans, inspection plans, material & equipment specifications, user requirement specifications, and standard operating procedures/work instructions.
- Conduct process validations and process risk analysis for new product introductions.
- Evaluate “out of specification” results and associated corrective actions within the validation effort.
- Commitment to quality by striving for reliability and quality, continuously searching for ways to enhance performance and meeting all training and documentation criteria.
- Responsible for monitoring and reporting to pre-established KPI metric on the newly implemented product transfer for a period of 3-6 months.
- Must ensure achievement of KPI’s before responsibility is transitioned to Manufacturing Engineering for 3+ years of quality or validation engineering experience in the medical device, or equivalent, industry experience.
- A minimum of a bachelor’s degree in Chemical Engineering, Materials Science, Mechanical Engineering, Industrial Engineering or a related discipline is required. A Master’s degree is preferred.
Quality Engineer – UT
Bachelor’s Engineering Degree preferred
- Minimum of 3 years’ relevant quality work experience.
- Experience in risk-based validation of configured-COTS and custom software systems.
- Good understanding of supply chain system operation.
- Proficient in Visual ERP workflows and operations to support FDA / ISO regulated activities.
- Working knowledge of Infor Visual Manufacturing ERP system modules: Receiving Inspection, Purchasing, Planning, Inventory, Warehouse, Work Orders, Shipping, etc.
- Proficient in Microsoft Office applications including, but not limited to Word, Excel, Outlook, Visio, PowerPoint, etc.
- Good understanding of 21 CFR Part 820, 21 CFR Part 11, ISO 13485, ISO 14971, GAMP 5, Good Documentation Practices (GDP).
- Understanding of SQL Server database concepts.
- Works independently and contributes to the validation of the ERP system
This position supports the validation of Visual Manufacturing ERP system so that it is compliant with internal company procedures, applicable industry standards and regulations. This resource will work in a regulated environment to support GxP operations for Visual ERP software validation. The contractor will work closely with the Business, Subject Matter Experts, IT, Quality and Validation personnel to validate the Visual ERP system. It is imperative that this individual be able to write test scripts for Visual ERP. The contractor will be required to provide their own laptop and be available to work on site for the duration of this assignment.
Design Quality Engineer – Mansfield, MA
- Ideal candidate will be supporting the development and manufacturing of medical devices in conformance with quality system regulation, ISO 13485, MDD, ISO 14971, IEC 60601 and other Regulatory standards.
- Incumbent will ensure internal Design Control policies and procedures comply with regulations and external standards, including software regulations, risk management, and change control.
- This person will lead all risk management activities, ensure procedures and files are maintained to State of the Art, and ensure all applicable staff are sufficiently knowledgeable and contributing to streamlining and continuous improvement of the product development process to ensure robust and efficient development and launch of new and innovative healthcare products.
- In addition, they’ll provide guidance for the application of internal development procedures, including design control, to the product development teams across all levels of the organization throughout multiple disciplines including R&D, RA, Program management, and marketing.
- DFSS, ISO 14971, Design Controls, FMEA, DFMEA, DFSS, Six Sigma Black Belt would be ideal, CQE, Reliability Engineering, Statistical Techniques, Sampling Size Justifications, Minitab, Software Validation, and working knowledge of electro-mechanical devices, software validation methods, and/or plastics related to manufacturing processes (i.e. extrusion, injection molding, RF Welding, etc.) familiarity with gage and inspection techniques. Strong collaboration, negotiation, and conflict resolution skills.
Quality Assurance/ Validation Experience/ Drug Safety Associate – Princeton, NJ
- QA review and approval of related transition change tickets. Ensure any deviations are documented, remediated, and closed.
- Track and ensure all assets have a final disposition. Ensure the qualification of migration software or applications used to move GxP applications.
- Ensure qualification documentation is efficiently managed and available for inspection.
- Participate in status calls representing IT Quality Management. Serve as a qualification subject matter expert on the transition project.
- Maintains close communication with stakeholders and team members to keep apprised of project status and timelines.
- Reports project status to management. Assist in the preparation of summary reports
- Degree in computer science, information technology, life science or 5 years-experience in software quality assurance in the life sciences industry.
- Technically conversant in concepts and techniques related to servers, databases & storage devices.
- Working knowledge of GAMP5 concepts, 21 CFR Part 11 and ITIL.
- Must have change management experience, preferably ServiceNow change management experience.
- Previous experience supporting computer system validation efforts including authoring qualification deliverables.
- Strong oral and written communication skills in English. Proficiency in MS Office suite.
- Experience with electronic document management systems and testing applications such as HP ALM/HP Quality Center is a plus.
Analytical Bench Chemist – Charles City, IA
Consultant will be required but not limited to the following:
- Perform a wide variety of analytical chemical analyses for release of raw materials, intermediates and small molecule API drug substance with a proven ability in general wet chemistry and chromatography (HPLC, UPLC, GC).
- Perform instrument maintenance and troubleshoot equipment as needed
- Perform method development including instrument parameters, new instruments and method improvement studies.
- Adhere to all EPA, FDA, cGMP and DEA regulations and internal SOPs as they relate to the operation of the Quality Control lab and general operation of the chemical production facility.
- Responsible for coverage of all job duties typical for analytical method development and validation.
- Experience with Wet Chemistry, Chromatography (HPLC, UPLC, GC) -MUST, cGMP Regulation knowledge – PREFFERRED.
- Experience in small molecule environment, Extensive knowledge of analytical instrumentation – PREFERRED
Analytical Chemist – Princeton, NJ
Pharmaceuticals (Cell Therapy)
- Establish and develop analytical methods. Work with Quality Control and other Operations groups to trouble-shoot and improve existing analytical methods.
- Design experimental plans based on the defined deliverables, planning the activities to meet the project timelines by working closely with project managers.
- Routine sample analysis to support process development. In summary, the responsibilities include method establishment, development and routine sample analysis to support process development and pilot production.
- The analytical methods routinely used include A280, capillary Gel Electrophoresis (cGE), capillary Isoelectric Focusing (cIEF), ELISAs, liquid chromatography (U/HPLC) and quantitative PCR (qPCR).
- Hands-on exp with A280, cGE, cIEF, ELISAs, chromatography and/or qPCR and LARGE MOLECULE is a MUST.
- Working knowledge of GMP/ GLP regulations in cGMP/ cGLP manufacturing environment STRONGLY PREFERRED.
- Routine use of MS Excel, MS PowerPoint and MS Word is a MUST excellent writing, communication and presentation skills a MUST.
PLEASE APPLY WITH 2-3 REAL WORLD EXAMPLES OF WHERE YOU HAVE THE ABOVE EXPERIENCE!
The ability to perform as a MOST IMPORTANT ASPECT OF LISTING (please highlight this experience thoroughly)
Laboratory Validation Engineer – NJ
The internal qualification team is spread thin across multiple projects. Hundreds of new pieces of equipment arriving across the multiple projects and need help with C&Q activities for new stand-alone equipment.
Consultant will be responsible for writing and preparing URS, commissioning and validation protocols IQOQPQ, and reports. Will be responsible for executing qualification protocols. Experience with qualifying stand-alone lab equipment such as HPLCs & UPLCs, LC, GC, pH meters and dissolution stations (Complete list of equipment below)
DI Water HPR HPLC LC
Glassware washer GC UPLC Dissolution station
Balance KF Titrator Disintegrator Refrigerator
pH meter Milli Q LCMS Moisture analyzer
Systems Engineer – Dublin, CA
Ideal candidate will be someone that is compiling the Compliance Checklist and creating the Risk Management Files – not someone that just performs System Verification where they are merely taking the OUTPUT. This candidate will be performing the analysis and creating the risk files, creating the checklist, showing the evidence, running the tests, investigating the issues, etc. Needs to really take charge on developing and leading the team on Verification Procedure, rather than just following the guidelines and taking the output.
Candidate will be tasked with helping write test protocols, execute test protocols and documenting this work with test reports as they go. Main functions of the tests are to perform Risk Management and Product Safety for these ophthalmic medical devices. Must be fluent in the main compliance standard IEC 60601-1 for electrical safety, risk management files, and extensive documentation to ensure the products are safe to release to manufacturing.
Client needs a System Engineer to support new product development. Fast-paced R&D environment and a very recently released product that they are updating with major features, essentially a 1.5 version of a pre-existing product. This engineer will be helping with tasks on the prior generation of the product and helping with sustaining and testing tool fixtures and modules, etc. Emphasis on Test Compliance as opposed to Quality Compliance – prior candidate was very strong but was used to a much more stringent Government-regulated environment, whereas this is product development and R&D with firm deadlines.
CSV Specialist – Palo Alto, CA
6 months+ – 12 months Ext
Project Overview- ARGUS HUGE +
Strong validation/CSV documentation, especially strong in creation of test scripts (Config IQs/OQs/PQs) and test execution.
Ideally prefer local candidates if available with system knowledge in Argus AE system (preferred)
Knowledge of different types of hosting – on-prem/in-house, Vendor hosted/SaaS, multi-tenant, etc. is desirable
7-8 years of CSV
ARGUS (system/workflow/business process)
Validation/ CSV documentation
creation of test scripts (Config IQs/OQs/PQs)
Validation specialist / CSV support – Albuequerque NM
Looking for a validation resource to support annual equipment qualification and connect PDA system to stand alone equipment. 1 example would be connecting their new autoclave to this system. This will also involve writing test scripts, protocols and checking data integrity. Consultant will aseptic validation experience and computerized system validation (21 CFR part 11)
Individuals with computer system validation experience (e.g., does their experience involve manufacturing equipment as well as laboratory equipment, software upgrades, install of new computerized systems)
Clinical Project Manager – Princeton, NJ
- Risk Management Capability – Develop a business case for a comprehensive Risk Management capability that includes end-to-end risk management for a study including standardized risk scoring, mitigation action tracking, and enhanced analytical capabilities.
- Non-Inspectable Document Repository – Gather business requirements and develop business case and solution assessment.
- Data flow and Quality Metrics – develop detailed business requirements.
- The Program manager will manage these activities, including the timeline and managing the budget.
- Various vendors may be used for some of the work, so those vendors and costs must be managed, as well as managing the financial processes (POs, invoices, etc.).
- Upon completion, the Risk Management Capability will move into implementation, and the ideal candidate will then project/program manage that work.
- Beyond the typical deliverables and activities as outlined in the Level PM/Program manager position, list any specific responsibilities & deliverables that you want to call out or emphasize. Should also use this space to call out job responsibilities for a hybrid role.
- Ability to manage the assessment phase of multiple projects, including business case development.
- Clinical Domain experience is a plus. Clinical Risk Management is a strong plus.