Job Title: Application Monitoring EngineerLocation: Hybrid at Client Locations – 3 Days a Week in the officeDuration: 12+ Months Contract To HireOnly on W2
Job description:Reason for opening: Resources are needed to support SRC/ REC activities.
Team Background and Preferred Candidate History:Candidate preferred industry background:*Financial background preferred*Needs experience in development and monitoring
Key responsibilities:1. Knowledge onboarding2. Development work around the functionality of the software3. After development, the position will move to monitoring-THIS IS A MUST FOR HM
Must have technical skills/experience:DynatraceLogscaleJavaMicroservicesKafkaMongoDBDevelopmentMonitoring
Flex Skills: Leadership experience
Soft skills: Communication skills
Education: Bach minimum
Years of experience: 4-6
Role Differentiator: What is different about this specific role compared to other hiring with the same skill set?
Interviews : *1st interview will be one on one; 2nd interview possibly panel
Job Position: Requirements AnalystLocation: San Diego CA 92121 (Hybrid – 3 days onsite per week)Duration: 6 months
Job Description:The Requirements Analyst will support various PLM, ALM, and SAP-related activities for several sustaining engineering and some new product development projects. This role will collaborate with the required document owners to make changes to design control documentation and data via document management processes according to the QMS. Associate will work closely with R&D engineering, marketing, operations, manufacturing plants, quality, medical affairs, and regulatory affairs functions. The role will require strong cross-functional collaboration, communication, organization, and time management skills.This job opportunity is heavily reliant on the ability to manage data and produce deliverables that are dependent on various product and project specificities. There is a heavy need on producing accurate and time-sensitive deliverables, with a focus on cross-functional collaboration between multiple teams and stakeholders, database and document remediation, process improvement, and data integration with proper alignment. A successful candidate will quickly become comfortable working with new and unfamiliar systems, have the capacity to operate a multitude of work items simultaneously, and effectively coordinate work requests across functional team members.Key Responsibilities:Manage Requirements, Specifications, User Needs, Hazards, and other controlled documents within DOORS database (e.g. create, update, link, data alignment, and maintain).Produce PRDs, Specs, RTMs, and a surplus of interim exports daily.Function as DOORS test administrator for the creation of VVP and VVR.Apply product and project knowledge to harmonize discrepancies across different deliverables.Support audits in finding unclear or missing information found in interconnected documents.Collaborate all DOORS-associated documents in SAP following data transcription.Assist with data migration activities between DOORS and Polarion, and document migration between SAP Tahiti and Teamcenter as needed.Assist teams with DOORS support functions including installation, user accounts, and system updates. Ensure projects and initiatives are delivered, providing consistent and effective communication on status and managing escalation and avoiding risk.Minimum Qualifications:Bachelor’s degree or higher in Information Technology, Engineering, Computer Science, or a related field is strongly preferred.Minimum 1-3 years of experience working with database management, engineering documentation, technical writing, or demonstrated capability.Proficiency in Microsoft applications is required (Excel, Word, PowerPoint, Outlook).Experience working in a healthcare or medical device development environment is preferred.Experience with ALM/PLM tools is preferred (SAP, IBM DOORS, Teamcenter, Polarion).Other Required Skills:Positive attitude with an aptitude for multitasking and critical thinking.Excellent written communication skills in English; strong interpersonal skills.Robust organizational skills; able to manage complex details and multiple synchronous tasks with an emphasis on quality and efficiency.Able to work independently and with a group, manage time effectively, and prioritize workload.Willingness to learn and adapt to new challenges, processes, and technology.
Job Title: Quality Engineer IILocation: San Diego, CA 92121Duration: 12 months
Job Description:As directed by the Quality Engineering Leader, the Quality Engineer II is accountable validation execution for manufacturing equipment and support in process validation or verification studies. Successful performance requires close work with quality management, operations, suppliers and/or Clients associates to assure compliance with all Client quality policies, procedures, and practices.Must demonstrate a working understanding of the ISO 13485 Quality Systems Regulations on Class I/II/II products. Preferred core experience in Quality Assurance, Quality Control, Validation (IQ,OQ,PQ) and Nonconformance management for regulated devices(i.e.: Good Manufacturing Practices, ISO, FDA). Proven ability to develop solutions to a variety of problems of moderate scope and complexity, using policies and procedures for guidance.Job Responsibilities: (Primary Duties, Roles, and/or Authorities)Experience performing equipment and process validation studies such as writing and/or reviewing protocol, report, data analysis and deviations for new, existing and site relocation activities.Have a working knowledge of medical device or biological equipment maintenance from Quality standpoint such as Preventive Maintenance, Calibration and Out Of Tolerance activity support to the site and equipment owners.Author and execute installation, operational, and performance qualifications for analytical and manufacturing equipment.Execute validation and qualification of GMP equipment and functions throughout the manufacturing facility.Review and update FMEA or Risk documents as needed for validation activity for the sitePerform additional duties to ensure business continuity during the relocation of the manufacturing processes into new area. Duties include but not limited to execution of QA inspection to support dual operations, review and approval of documents such as batch records to support finished product release.Education and Experience:BS Biological Sciences, Chemistry, Bio-tech engineering, Bio-engineering or related fieldMinimum of 3-5 years of experience for QE II and 5-7 years for Sr. QE in Medical Device, Biotech or Pharma Industry.Knowledge and Skills:Strong verbal and written communication skills; ability to write technical documents. Knowledge of quality system methodologies.Statistical Analysis basic knowledge e.g. Minitab or Excel.Strong knowledge of Process Validation and equipment validation.Strong understanding and knowledge of ISO 9001, ISO 14971, and/or ISO 13485 (Design Control, Supplier Management and Risk Management).Hands-on experience using Six Sigma methodology.SAP knowledgeEquipment management systems such as BMRAM knowledge is preferred.The ability to work in teams and independently with minimal supervision to obtain results as required.Must be self-motivated/directed, organized, detail-oriented and able to multi-task projects.Physical Demands: (if applicable)General physical requirements: ability to work in a controlled environment.Ability to work with laboratory-grade equipment such as refrigerators, freezers, centrifuges, etc during validation work.
Job Position: Mechanical EngineerLocation: Durham NC 27703Duration: 12 monthsWorkdays/hours: Mon - Fri 8 AM – 5 PM
Job Description:We are currently seeking a Mechanical Engineer who will be responsible for various aspects of the design, development, test, and manufacturing of our pharmacy automation equipment. The focus of this role will be to maintain a product design that supports the Product Operations group and ensures consistent part sourcing at an acceptable cost point. This position may require the individual to participate in both new product development, as well as, sustaining activities with manufacturing teams, for our existing product fleet. Strong attention to detail, adaptability, communication, and a willingness to work in a collaborative team environment are skills that will support a high level of success in this position.Key Responsibilities:Work with procurement team to identify replacement components which have gone end of life or have drastically increased in part costing. Update and release design files to accommodate the new components.Design sheet metal, plastic, and machined parts and assemblies for use in automation equipment.Analyze and test the design of parts and assemblies to ensure that they meet design specifications, cost goals, and manufacturability requirements.Contribute to a multidisciplinary research and development team to conceptualize innovative new systems related to pharmaceutical automation.Work closely with in-house engineers and technicians, plus outside vendors, to develop cost-effective mechanical prototypes that also support electrical and software subsystems.Document part and system designs for sourcing, inspection, and internal use.Skills and Experience:Bachelor's degree in Mechanical Engineering or Mechatronics Engineering2+ years of related work experience.Previous classroom and/or work experience with solid modeling and analysis tools, SolidWorks experience preferred.Excellent analytical, technical, and problem-solving skills.Ability to thrive in a fast-paced team-oriented environment.Excellent verbal and written communication skills; ability to work across a variety of departments.Multi-tasking and time-management skills with the ability to prioritize tasks.Proficiency with Microsoft Office programs including Word, Excel, and Outlook.Work environment and physical demands:The characteristics described below are representative of those encountered while performing the essential functions of this position. When properly requested and when feasible (without undue hardship to the company), reasonable accommodations will be made to enable individuals with disabilities to perform essential job functions.Work will primarily be in an office setting with limited opportunities to be exposed to adverse environmental conditions.Work will be primarily working with fingers by picking, pinching, typing, and grasping often with repetitive motion.Must have visual acuity for viewing a computer screen, the ability to talk, hear and sit for extended periods of time.Must be able to carry, lift and push/pull up to 5 pounds frequently and up to 30 pounds occasionally.Additional physical duties may be required as necessary.
