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If you are interested in joining a dynamic and challenging work environment that will put your skills to the test, please write us (resumes@labchemspr.com) for more information on the job opportunities we have available. You can also visit us in clasificados online jobs portal.
Supplier Quality Engineer
Onsite, Fulltime
Responsible for a project that applies to Incoming Inspection deliverables: Supplier Qualifications, implement receiving inspection process and components transfer plan. Will approve validations (IQ/TMV), will communicate directly with suppliers to support documentation/validations for suppliers’ approval process, develop Product Qualification Plan, create and/or approve change requests for equipment implementation and suppliers’ approval process. Full Time, On-site, Professional Services Contract.
BS or MS in Engineering with 3-5 years of experience in Quality Engineering, Validations or Process Engineering, preferably in pharmaceutical or medical devices regulated industries. Experience with validation activities, GDPs and GMPs. Solid documentation practices, excellent computer skills. Ability to read, comprehend, write and speak English.Good communication and interpersonal skills.
Quality Engineer
Onsite, Fulltime
Responsible for providing QE support investigating manufacturing product quality and compliance issues (CAP, non-conformances, observations) for all production phases prior to final release. Optimize manufacturing processes using engineering methods (Six Sigma, Lean Mfg.) for continuous process improvement. Validation protocols/reports revision and approval. Develop training and documentation materials for manufacturing. Full Time, On-site, Professional Services Contract.
Bachelors degree in Engineering with 1-3 years of experience in Quality, Validations or Process Engineering, preferably in GMP regulated manufacturing. Previous experience with product impact assessment, qualification and validation processes. Basic statistical background. Excellent computer skills. Ability to read, comprehend, write and speak English. Good communication and interpersonal skills.
Validation Specialist
Onsite, Fulltime
Bachelors degree in Engineering or Sciences with at least 2-3 years of experience in relevant manufacturing and validations activities, product development, change control, or related areas in GMP regulated manufacturing. Experience with protocol development and execution. Experience collecting data and preparing technical reports/ assessments. Ability to apply advanced mathematical concepts and operations. Ability to discuss normally encountered technical or project management issues, both verbally and in written form. Ability to work as a collaborative team member. Communicate effectively at all levels. Ability to read, comprehend, write and speak English.
CSV Engineer
Onsite, Fulltime
Support Engineering and Manufacturing in the generation, execution and implementation of validation activities for automated equipment. CSV lifecycle documentation development/revision: URS, VP, data integrity revision, test protocol development. Protocol execution and final report generation. Attendance to meetings for project details coordination. Generate Standard Operating Procedures (SOP) for computerized and manufacturing systems. Generate changes reports or documents for new or modified equipment. Generates Final/Validation Report in accordance with actual FDA certification concepts. Full Time, On-site, Professional Services Contract.
Bachelors Degree in engineering. 3+ years of manufacturing experience in Automation and PLC systems within pharmaceutical or medical devices regulated industries. Must have experience in Computerized System Validation Cycle (CSV). Knowledge and experience validating automated manufacturing equipment (Vision Systems, PLC’s, robots, HMI’s, etc.). Fluency speaking and writing in English and Spanish.
Manufacturing Engineer
Onsite, Fulltime
Provides daily support of production operations. Individual will be required at times to make complex technical recommendations on product quality and reliability to sustain business activities. Will support New Products Introduction (NPI) and process transfer activities in a regulated manufacturing environment. Writes Process and Equipment Specifications when applicable. Supports equipment development efforts for new devices, and process improvements. Supports investigations process (NCRs, Complaints) and teams with Manufacturing and QA personnel for review and disposition of investigation on time. Full Time, On-Site, Temporary or Professional Services contract.
Bachelor’s Degree in Engineering with 1-3 years of manufacturing experience in pharma or medical device manufacturing environment. Experience with equipment qualification and process validation activities is preferable. Statistical analysis (GR&R) and data management experience, including use of statistical tools such as Minitab. Ability to read, comprehend, write and speak English. Ability to work independently with general supervision on larger, moderately complex projects / assignments.
Project Manager
Onsite, Fulltime
Responsible for the management of manufacturing projects. Execute required activities for initiation/planning, execution, controlling, and closing phases. Create and manage project schedule and action item trackers. Develop a high-level milestone plan for the program and manage program changes in accordance with the change management plan to control scope, mitigate risks, quality, schedule, cost, and contracts. Establish and maintain program stakeholder relationships, expectations, and communications, both internal and external to the organization. Manage and control changes from original scope through scope change process. Facilitate meetings as necessary to serve as conduit between project/team members in all cross-functional groups. Drive communications and escalate issues/risks to the project critical path timeline, resources, budget and scope. Full Time, On-site, Professional Services Contract.
Bachelors degree in Engineering, Science or related, with at least 8-10 years of Program/Project Management experience, preferably in regulated manufacturing environment. Preferred Qualifications: Degree. Experience with regulatory agency guidelines for medical device manufacturers. Project Management Professional (PMP) Certification is preferred. Proven record managing multiple complex, large-scale projects. Ability to prioritize projects. Advanced skills in Microsoft Project. Excellent verbal and written communication skills in English. Working experience managing resources. Possess and display sound judgment; initiative; flexibility and detail-orientation. Knowledge and work experience with Project budgets and financial management.
Sr. Project Engineer
Onsite, Fulltime
Bachelors degree in Engineering with 5-8 years relevant experience. Proven experience with project and budget management. Time management skills. Ability to solve design and engineering problems. Proven track record managing multiple/large-scale projects. Maintenance work experience, Instrumentation and Process Control System work experience is preferable, as well as Professional Engineer (PE) License. Excellent verbal and written communication skills in English.
Chemist
Onsite, Fulltime
Perform Quality Control analyses according to Specifications, Test Methods, SOPs, Pharmacopeia (USP, EP, JP) following all Safety rules applicable. Prepare accurate analysis reports, prepare and standardize solutions. Conduct analytical testing and release of raw materials and packaging components. Analyze complaint and Stability samples in a timely and accurate manner, report any quality issue to the Lab Manager. Assure analytical results are neat and accurate. Full Time, On-Site, Temporary contract.
Bachelor’s Degree in Chemistry, 0-1 years of experience in laboratory testing, preferably in regulated manufacturing of pharmaceutical or medical devices. Ability to operate laboratory test equipment, computer literate, able to interpret and convert units of measure such as temperature, pressure, flow, area, mass, distance, volume, among other. Good mathematical skills. Previous experience in GMP environment is preferred. Ability to follow written procedures and/or verbal instructions. Ability to read, comprehend, and write in English. Good communication and interpersonal skills.
Equipment Maintenance Technician
Onsite, Fulltime
Performs installation, maintenance, and repairs on line manufacturing or plant equipment. Locates and diagnoses failures, replaces defective components, and performs basic troubleshooting using standard electronic equipment, detailed drawings, diagrams, sketches, specifications, prints, manuals, and verbal and/or written instructions. Maintains appropriate maintenance and repair logs. Calibrates, adjusts, tests, diagnoses, and maintains equipment, components. Uses a variety of hand, power, and test tools and equipment. May redesign optical, vacuum, electrical, electronic, or mechanical systems for incorporation on existing manufacturing equipment. May estimate labor and equipment costs and prepare requisitions as required. Uses schematics, diagrams, written and verbal descriptions or defined plans to perform testing and troubleshooting on electronic or mechanical components, equipment or systems. . Full Time, On-Site, Temporary contract.
Associate or Bachelors Degree in Electronics, Engineering Technology, Metrology, Industrial Technology or related field. Requires 3-5 years of relevant experience with machines maintenance and calibrations in medical device or pharmaceutical industries. Experience with Cognex Vision systems, PLCs (Siemens), automatic systems, motion control platforms (Aerotech) is preferable. Experience programming Mitsubishi, Allen Bradley or Siemens PLCs is preferable. Working knowledge in GMP’s and SOP’s is required. Knowledge using SAP, Maximo or other similar systems is a plus. Basic computer knowledge is required. Ability to read, comprehend, and write in English. Availability for different work schedules and shifts may be needed.
Calibration/Metrology Technician
Onsite, Fulltime
Calibrates electronic test measuring equipment and signal generating equipment to conform to set standards. Tests, calibrates, adjusts, and maintains electromechanical, mechanical, optical, pneumatic, hydro mechanical, and pressure type measuring and indicating instruments. Sets up calibration sequences, methods and procedures according to detailed specifications, blueprints, drawings, and requirements. Disassembles, cleans, repairs, and replaces defective parts of test equipment such as pressure gauges and tension meters. Provides technical support in areas such as production, operations, maintenance, safety, testing, process improvement or product development. Performs tests, interprets data and develops reports. Uses schematics, diagrams, written and verbal descriptions or defined plans to perform testing & troubleshooting on electronic or mechanical components, equipment or systems. Full Time, On-Site, Temporary contract.
Associate or Bachelors Degree in Instrumentation, Electronics, Engineering Technology, Metrology, Industrial Technology or related field. Certificate in Metrology or Calibrations is preferable. Requires basic job knowledge of systems, techniques and procedures with at least 2-3 years of relevant experience in manufacturing, preferably medical devices or pharmaceutical regulated industries.
Bilingual, able to work under moderate supervision while keeping good communication with all areas. Knowledge in SAP is preferable. Availability for different work schedules and shifts may be needed.
Lab Technician Microbiology
Onsite, Fulltime
Perform microbiological sampling and testing for product release, microbiological control and protocols as needed following company specifications and cSOP’s. Assure that complies with company policies and internal and external regulations. Perform environmental (water, room air, compressed air, nitrogen and surfaces) test, Bacterial Endotoxin test, bioburden and product and garments particulate matter tests, microbiological/ mold identification, microbial ingress studies. Performs microbiological testing for product. Performs growth tests to culture media. Prepared media requested to perform the different testing at the Micro Lab. Control materials and media inventory. Carry-out weekly inventory of reagents, wastes, media and sampling equipment. Full Time, On-Site, Temporary contract.
Bachelors degree in Microbiology or related field with 6 months to 1 year of previous experience in a laboratory for a manufacturing environment (medical device or pharmaceutical industry is preferable). Knowledge of GMP and GLP. Experience with Spectrophotometer, Centrifuge, Autoclave, Particle Counter, Microscope, VITEK general and specialized laboratory equipment. Good oral and written communication skills in Spanish and English. Working experience with Microsoft Office (Excel, PowerPoint, Word) and Internet navigation. Availability for different work schedules and shifts may be needed.