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Kelly® Science & Clinical is seeking several Biomanufacturing Associates for Direct Hire positions at a premier biotech company in the Portland, OR area. If you're motivated, detail-oriented, and eager to contribute to a fast-paced manufacturing environment, this is a great opportunity to take your career to the next step!

Pay Rate:

2A: Base pay $21/hour + shift differential = $26.12/hour

2B: Base pay $21 + shift differential = $25.86/hour

Schedule:

2A: Alt Sat, Sun-Tues, 7:00pm-7:30am OR

2B: Alt Sat, Weds-Fri, 7:00pm-7:30am

Overview:

As a Biomanufacturing Associate, you will play a vital role in producing high-quality, custom oligonucleotide products that power the future of biotech. In a dynamic and fast-paced lab environment, the role involves adhering to SOPs, operating automated lab equipment, documenting processes, and supporting manufacturing schedules, with a strong focus on quality and safety practices.

Company Culture

Fast paced environment without too much structure/red tape to make decisions. Growth opportunities available within a 110K sq ft state-of-the-art “factory of the future” that was completed and started production in 2022-2023.

Responsibilities:

• Contribute to the production of high-quality custom products in a high-throughput lab, following established SOPs and manufacturing standards.
• Efficiently perform molecular and cell biology processes, including PCR and DNA purification, contributing to the production of custom DNA-based products.
• Independently handle the operation of various laboratory equipment and robots while ensuring safety and adherence to ISO and lean manufacturing practices.
• Thoroughly document processes and update work instructions, supporting troubleshooting and maintaining high attention to detail.
• Organize shipping of products and maintain consistent work output under minimal supervision.

Qualifications:

• Bachelor’s degree in Biology, Biochemistry or related field OR previous experience working in GMP environment.
• Fresh graduates or candidates with relevant laboratory experience in a manufacturing or high-throughput biotech setting will be considered
• Familiarity with molecular biology techniques such as PCR, DNA quantitation / purification
• Strong documentation skills with attention to detail
• Ability to work independently, follow SOPs precisely, and work safely with chemicals and hazardous materials
• Good computer skills, including proficiency with Excel and Word
• Comfortable working in a team-oriented laboratory environment and standing for extended periods
• Ability to work on the night shift

Seize the opportunity to be part of something extraordinary where your work contributes to revolutionary advances in health, sustainability, and technology. Apply now and help us write the future of DNA synthesis!

About Ashley

Ashley Furniture Industries, Inc. is the largest manufacturer of furniture in the world. Established in 1945, Ashley offers one of the industry’s broadest product assortments to retail partners in 123 countries.

About the role:

The IoT Developer – Smart Manufacturing is responsible for architecting, implementing, and sustaining industrial IoT integrations across manufacturing facilities to enable Smart Factory transformation.

This role operates at the intersection of industrial automation and enterprise systems, connecting plant-floor equipment (PLCs, sensors, robotics, packaging lines, and scanning systems) to enterprise platforms including the Execution Operations Platform (EOP), Manufacturing Execution Systems (MES), ERP systems, and robotics execution systems.

This is a hands-on, plant-facing engineering role requiring real-time problem solving during machine installations, go-lives, and commissioning events. The position directly enables production visibility, material traceability, quality validation, and operational optimization.

The IoT Developer plays a critical role in scaling standardized connectivity architecture across multiple facilities.

Key Responsibilities

1. Industrial IoT Integration & Architecture

• Integrate PLCs, robotics, sensors, and machine controllers using MQTT, OPC-UA, REST APIs, and secure messaging protocols
• Develop and maintain edge-to-cloud data pipelines for real-time manufacturing data
• Design standardized machine connectivity frameworks for multi-site scalability
• Implement structured data models for production, quality, and downtime capture
• Ensure secure data transmission and storage aligned with IT and cybersecurity standards
• Develop reusable integration templates to accelerate future deployments

2. Smart Factory Enablement

• Connect Execution Operations Platform (EOP) with MES, ERP systems, and enterprise applications
• Enable material tracking technologies (RFID, barcode, serialization, vision systems)
• Capture and validate real-time production, scrap, yield, and dimensional data
• Support deployment of Control Tower and plant observability systems
• Enable digital twin models of machines and production lines
• Standardize event-driven data structures for enterprise reporting and analytics

3. Automation Expansion & Plant Deployments

• Participate in Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT)
• Validate integration reliability prior to production go-live
• Support commissioning and startup during compressed installation windows
• Troubleshoot PLC and machine communication during live production
• Work directly with automation vendors, controls engineers, and plant operations teams
• Scale successful implementations across additional facilities

4. Proactive Operational Support & Reliability

• Monitor machine connectivity and data health across sites
• Troubleshoot IoT communication failures and production-impacting issues
• Improve system resilience and fault tolerance
• Reduce downtime through early detection and rapid resolution
• Continuously harden and optimize plant integration architecture

Preferred Qualifications

• Smart Factory or Industry 4.0 implementation experience
• Experience integrating material tracking technologies (RFID, barcode, computer vision)
• Exposure to enterprise genealogy or graph database systems (e.g., Neo4J)
• Participation in multi-site rollouts
• FAT/SAT experience during machine installations
• Experience supporting robotics or automated packaging systems

Key Competencies

• Industrial systems thinking
• Structured data modeling
• Cross-functional communication
• Calm execution under production pressure
• Root cause analysis
• Standardization mindset
• Documentation discipline

Apply today and find your home at Ashley!

Corporate Social Responsibility

• We are an equal opportunity employer and provide a drug-free working environment. While Ashley appreciates the interest of all candidates only those meeting specific position requirements may be contacted. Principals Only.

THE COMPANY:

Juul Labs's mission is to transition the world’s billion adult smokers away from combustible cigarettes, eliminate their use, and combat underage usage of our products. We have the opportunity to address one of the world’s most intractable challenges through a commitment to exceptional quality, research, design, and innovation. Backed by leading technology investors, we are committed to the same excellence when it comes to hiring great talent.

We are a diverse team that is united by this common purpose and we are hiring the world’s best engineers, scientists, designers, product managers, operations experts, and customer service and business professionals. If the opportunity to build your career is compelling, read on for more details.

ROLE AND RESPONSIBILITIES:

• Lead design reviews (DFM) for R&D prototype fixture design and manufacturing equipment and custom tooling to ensure readiness for new product launches.
• Drive Automation strategy, ensuring hardware can meet strict performance metrics & regulatory requirements
• Support the end-to-end development of complete automation systems, from initial design to installation at global contract manufacturing sites.
• Serve as the primary technical lead for equipment qualification, managing Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT).
• Systematically troubleshoot complex system failures to the component level, ensuring minimal downtime during product scale-up.
• Determine the root cause of equipment and system test failures.
• Deep understanding of machine design/qualification including calibration, correlation, capability, repeatability and reproducibility with deep understanding of data analytics and statistical method
• Develop and/or oversee the writing of User Requirement Specifications, Statements of Work and manufacturing requirement specifications

• What are 3-6 deliverables that would indicate success in the position?
• Successful FAT/SAT: Seamless execution and documentation of equipment qualification for at least two major production lines.
• Optimized Yield: Development of statistical reports that optimize pass/fail criteria, leading to a measurable reduction in scrap rates.
• Process Stability: Completion of Gauge R&R and CPK studies that prove machine capability (Cpk > 1.33) for critical-to-quality dimensions.
• Failure Resolution: Reduction in "Mean Time to Repair" (MTTR) through the creation of structured troubleshooting guides for CMO partners.

PERSONAL AND PROFESSIONAL QUALIFICATIONS:

• You are engineering the precision systems that deliver on Juul’s mission of providing high-quality alternatives for adult smokers globally. This role sits at the intersection of high-stakes manufacturing and cutting-edge data analytics, offering the unique opportunity to own the technical success of a major product launch from design through global scale-up. You will be the architect of the processes that ensure every product meeting a consumer is safe, reliable, and consistent.
• 5-8 years of industry experience in integration, design of equipment and automation.
• Deep expertise with system design and integration and high-volume manufacturing.
• Technical expertise in designing automation for handling high precision processes.
• Strong problem-solving skills in mechanics, materials and thermal stress.
• Experience in both development and manufacturing environments.
• Advanced knowledge with SoildWorks
• Engineering knowledge of mechanical engineering sciences (mechanics, machine design, dynamics and manufacturing processes) with the ability to apply these principles to solve customer challenges.
• Strong analytical skills and attention to detail for creation of manufacturing drawings.

Nice to have:

• Previous experience in tobacco secondary processing, specifically with Heat-Not-Burn (HNB) consumables or electronic nicotine delivery systems
• Familiarity with high-speed tobacco rod makers, tip-attachment machines, or complex multi-segment combiner technology.
• Experience working within highly regulated quality frameworks (e.g., ISO 9001, GMP, or tobacco-specific regulatory environments).
• Understanding of serialization and "Track and Trace" systems used for excise tax compliance or anti-counterfeiting measures.
• Experience managing technical transfers or system upgrades at international contract manufacturing sites

EDUCATION:

• Bachelor’s degree in mechanical engineering or industrial systems engineering.
• GD&T principles

JUUL LABS PERKS & BENEFITS:

• A place to grow your career. We’ll help you set big goals - and exceed them
• People. Work with talented, committed and supportive teammates
• Equity and performance bonuses. Every employee is a stakeholder in our success
• Cell phone subsidy, commuter benefits and discounts on JUUL products
• Excellent medical, dental and vision, disability, and life insurance, plus family support, wellness, legal, and employee assistance program benefits
• 401(k) plan with company matching
• Plus biannual discretionary performance bonuses

SALARY RANGES:Salary varies by role, level and location, and is dependent on the cost of labor in a givengeographic region among other factors. These ranges may be modified at any time.

SALARY RANGE:: $150,000 USD - $184,000 USD

ESSENTIAL DUTIES AND RESPONSIBILITIES

The essential functions include, but are not limited to the following:

· Support the execution of the Commissioning, Qualification, and Validation activities for our new Vial Filling system (e.g., washing/depyrogenation, aseptic filling, isolator/VPHP, glove integrity testers, environmental monitoring systems), including SAT, IQ/OQ, PQ, and Aseptic Process Simulation.

· Management of Equipment Vendors, including project execution, on-site maintenance and calibration visits, vendor-supplied training of operation and maintenance staff, management of continuous improvement projects, and spare parts criticality assessments.

· Responsible for delivering cycle development for the process including VPHP cycles for Isolator & transport systems, and preparation of required GMP documentation for filling process and recipes.

· Support the establishment of an electronic batch record system for filler and isolator setup, operation, and changeover.

· Support the transition from project to sustaining manufacturing and the ramp-up of production volumes in the future by improving equipment reliability through Continuous Improvement and TPM processes.

· Coordinate technical deliverables within the Aseptic Operations team to support successful process and product launches.

· Lead and participate in cross-functional groups to investigate and resolve technical issues, drive continuous improvement, and process optimization using tools such as DMAIC and FMEA.

· Manage change in the Vial Filling and/or Nest Filling areas as per site change control procedures.

· Participate in regulatory inspections e.g. FDA, DEA inspections as a Subject Matter Expert (SME).

BASIC QUALIFICATIONS (KNOWLEDGE, SKILLS, AND ABILITIES)

· Bachelor’s degree in engineering, Materials Science, Biology, or related discipline.

· Minimum 4+ years working in a cGMP environment, i.e. pharmaceutical.

· Exposure to parenteral processing equipment and operations, including formulation, filling, visual inspection, and packaging equipment.

· Front-line support of aseptic filling equipment and/or barrier systems, e.g. isolator or RABS.

· Demonstrated ability to solve technical problems and implement projects.

· Excellent interpersonal and communication skills across various levels of the organization.

· Strong Mechanical Aptitude.

· Interact with other functions (e.g. Manufacturing, Automation, Quality Assurance, R&D) and must be able to take ownership of and follow through on assigned projects.

· Ability to execute on-the-floor activities such as FAT, SAT, IQ/OQ, and Engineering batches.

· Willingness to adapt to changing priorities as project demands change.

· Ability to explain complex technical issues to external customers/agencies.

PREFERRED QUALIFICATIONS

· SME-level knowledge of high-speed aseptic filling and barrier system technology (isolator, RABS).

· Expertise in single-use components in drug product formulation, sterile filtration, and aseptic filling applications.

· Demonstrated management and delivery of large capital projects ($1MM +).

· Experience with greenfield facility Commissioning, Qualification, and Validation (CQV) and production startup desired.

Previous Pharmaceutical/Biotech experience is mandatory for this role

MMR Consulting is an engineering and consulting firm specializing in the pharmaceutical and biotechnology industries. Its services include Engineering, Project Management, and Validation.

MMR Consulting has offices in Canada, USA, and Australia.

This is an outstanding opportunity to join our growing team, where the successful candidate will work with a group of engineers involved in the design, commissioning & qualification, start-up and project management of various processes, systems, and facilities. The ideal candidate should possess leadership skills to lead teams of intermediate & junior engineers.

This role is for Sr. CQV Engineer will require to work on the validation of upstream and downstream bioprocess systems/equipment in the biopharmaceutical industry, as well as process equipment in pharma/biotech industries. The ideal candidate should possess leadership skills to lead teams of intermediate & junior engineers.

The work will require working out of client’s facilities, which are typically in the Greater Denver/Boulder Colorado & surrounding areas.

Responsibilities

• Provide technical guidance in the commissioning, qualification and start-up of various pharmaceutical / biopharmaceutical cGMP process equipment, utilities & facilities.
• Lead the development (for example, write test cases) of key qualification deliverables such as DQ, FAT, SAT, IQ, OQ and PQ during the project lifecycle.
• Able to perform field execution of qualification test cases and protocols.
• Support development of Project Validation Plans (PVPs) to ensure the action plan to test the system is applicable and relevant.
• Lead qualification processes throughout the project lifecycle to ensure timely completion and to ensure all quality and engineering specifications are met.
• Possess knowledge of relevant regulatory requirements and industry best practices on all or any of the following – Process equipment, clean utilities, automation systems, laboratory equipment, building & facilities
• Coordinate meetings with cross-functional departments, to drive project progress, facilitate decisions, and provide updates.
• Engage other departments, as required, in the design reviews and decisions.
• Travel may be occasionally required for meetings with equipment fabrication vendors or Factory Acceptance Testing (FATs).
• Work may require occasional support over shutdowns or extended hours, specifically during installation, construction, commissioning, qualification, and validation phases.
• Visit construction and installation sites, wearing necessary safety PPE.
• You may be involved with other aspects such as client-management (maintain key Client relationships in support of business development and pursuit of new work), project scheduling/budgeting, coordination of client and MMR resources for effective project delivery, supporting business development (providing technical support to the sales as required for proposals/opportunities), presenting at industry conferences/publishing papers etc.
• Supervise contractors during critical testing of system and equipment.
• Other duties as assigned by client, and/or MMR, based on workload and project requirements.
• As this position requires working on client sites, you will need to comply with the client’s safety rules including mandatory vaccination policies for COVID-19, where applicable
• Lead/Mentor a team of validation engineers/specialists.

Qualifications

• 12+ years of experience in commissioning, qualification or validation of various systems within the pharmaceutical/biotech industry.
• Previous experience in the pharmaceutical / biotech industry, with knowledge of requirements for cGMP operations.
• Validation experience such as cleaning validation, thermal validation, mixing studies, process validation, computer systems validation is an asset but not required.
• Experience with developing and executing validation projects to Risk-Based Commissioning & Qualification approaches, such as ASTM E-2500 or ISPE ICQ, is considered an asset, but not required.
• Experience with commissioning & qualification of process control systems (i.e. PCS, SCADA, Historians) and building automation systems are considered an asset.
• Experience with commissioning and qualifications of biotech process equipment, such as some, but not all, of the following: fermentation, bioreactors, downstream purification processes (chromatography, TFF, UF), CIP systems, Buffer systems, Clean Utilities would be an asset.
• Experience with Qualification or Validation of clean utilities and ISO clean rooms.
• Experience with preparation and execution of URS’s, DQ’s, RTMs, Risk Assessments, CPPs, VPPs, FATs, SATs, IOQs
• Lead teams of Validation staff, manage staff priorities, provide mentorship/oversight, help staff resolve issues. Leadership is considered an asset but not required.
• Possess leadership skills, and be able to take initiative to lead projects, involving multiple stakeholders, departments, and varying complexities.
• Possess mentorship skills, to coach and develop junior and intermediate employees.
• Engineering degree, preferably in Mechanical, Electrical or Chemical.
• Travel may be required on occasion.
• Ability to handle multiple projects and work in a fast-paced environment.
• Strong multi-tasking skills
• Ability to lift 50 lbs.

Compensation: 90,000$ - 115,000$ based on experience.

Equal Employment Opportunity and Reasonable Accommodations

MMR Consulting is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. Our hiring decisions are based on merit, qualifications, and business needs. We are committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please let us know the nature of your request.

Previous Pharmaceutical/Biotech experience is mandatory for this role.

MMR Consulting is a consulting firm specializing in the pharmaceutical and biotechnology industries. Our services include Project Management, Process, Automation, Facilities and Equipment CQV.

MMR Consulting has offices in Canada, USA, and Australia.

This is an outstanding opportunity to join our growing team, where the successful candidate will work with a group of specialists involved in project management, commissioning and qualification, of equipment, systems and facilities. The work will require working out of the client’s facilities.

This role is for C&Q Specialist to work on the commissioning, qualification, startup of upstream and downstream bioprocess systems/equipment in the biopharmaceutical industry, as well as process equipment in pharma/biotech industries. The ideal candidate should possess leadership skills to lead/mentor intermediate/junior specialists.

The work will require working out of the client’s facilities in Greenville, North Carolina.

Responsibilities

• Provide technical guidance into the commissioning, qualification and start-up of various equipment and facilities.
• Lead the development of key qualification deliverables during the project lifecycle to ensure project is well defined, and the action plan to test the system is applicable and relevant.
• Lead qualification processes throughout the project lifecycle such as VPP, Risk Assessments, RTM, FCCA/dRA, DQ, FAT, SAT, IQ, OQ and PQ as appropriate to ensure timely completion and to ensure all specifications are met.
• Prepare protocols, execute protocols, summarize data, resolve deviations, prepare final reports.
• Experience with C&Q parts washer and autoclave is required. Experience with C&Q of other process equipment, utilities, facilities is an asset. Thermal Validation experience is an asset.
• Coordinate meetings with cross-functional departments, to drive project progress, facilitate decisions, provide updates.
• Engage other departments, as required, for design reviews and decisions.
• Travel may be occasionally required for meetings with clients, equipment fabrication vendors or Factory Acceptance Testing (FATs).
• Work may require occasional support over shutdowns or extended hours, specifically during installation and commissioning / validation phases.
• Client-management (maintain key Client relationships in support of business development and pursuit of new work), project scheduling/budgeting, coordination of client and MMR resources for effective project delivery, supporting business development (providing technical support to the sales as required for proposals/opportunities), presenting at industry conferences/publishing papers etc.
• Visit construction and installation sites following all site safety requirements.
• Supervise contractors during critical testing of systems and equipment.
• Other duties as assigned by client, and/or MMR, based on workload and project requirements.

Qualifications

• Excellent written and spoken English is required including the preparation of technical documents in English
• Years of experience: 8+ years for years of experience in commissioning, qualification or validation of various systems within the pharmaceutical/biotech industry, where minimum 6 years should include direct C&Q experience with upstream or downstream bioprocess equipment/systems.
• Knowledge of requirements for a cGMP operations, including SOPs, Change Controls, Validation.
• Experience with developing and executing validation projects. Risk-Based Commissioning & Qualification approaches, such as ASTM E-2500 or ISPE ICQ, is considered an asset.
• Experience with commissioning and qualification of biotech process equipment (upstream or downstream or both), such as some, but not all, of the following: fermentation, bioreactors, downstream purification processes (chromatography, TFF, UF) is an asset.
• Experience with commissioning & qualification of process control systems (i.e. PCS, SCADA, Historians) and building automation systems (i.e. Siemens Insight / Desigo, JCI Metasys) are considered an asset.
• Experience with Qualification or Validation of clean utilities, ISO clean rooms, and Thermal Validation is considered an asset.
• Experience with preparation and execution of URS’s, DQ’s, RTMs, Risk Assessments, CPPs, VPPs, FATs, SATs, IOQs, NCRs, Final Reports.
• Lead teams of Validation staff, manage staff priorities, provide mentorship/oversight, help staff resolve issues.
• Possess mentorship skills, to coach and develop junior and intermediate employees.
• Degree, preferably in Mechanical, Electrical, Chemical, Biochemical, Electromechanical, Science or a related discipline.
• Ability to handle multiple projects and work in a fast-paced environment.
• Strong multi-tasking skills

Compensation: 80,000$ -110,000$ based on industry experience.

Equal Employment Opportunity and Reasonable Accommodations

MMR Consulting is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. Our hiring decisions are based on merit, qualifications, and business needs. We are committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please let us know the nature of your request.

Previous Pharmaceutical/Biotech experience is mandatory for this role.

MMR Consulting is an engineering and consulting firm specializing in the pharmaceutical and biotechnology industries. Its services include Engineering, Project Management, and Validation.

MMR Consulting has offices in Canada, USA, and Australia.

This is an outstanding opportunity to join our growing team, where the successful candidate will work with a group of engineers involved in the design, commissioning & qualification, start-up and project management of various processes, systems, and facilities. The ideal candidate should possess leadership skills to lead teams of intermediate & junior engineers.

This role is for C&Q Manager will require to work on the validation of upstream and downstream bioprocess systems/equipment in the biopharmaceutical industry, as well as process equipment in pharma/biotech industries. The ideal candidate should possess leadership skills to lead teams of intermediate & junior engineers.

The work will require working out of client’s facilities, which are in Boulder, Colorado.

Responsibilities

• Provide technical guidance into the commissioning, qualification and start-up of various equipment and facilities used in life science manufacturing, such as bioreactors, tanks, CIP, Buffers, Media, Chrom, TFF, washers & autoclaves, etc.
• Lead the development of key qualification deliverables during the project lifecycle to ensure project is well defined, and the action plan to test the system is applicable and relevant.
• Lead qualification processes throughout the project lifecycle such as VPP, Risk Assessments, RTM, DQ, FAT, SAT, IQ, OQ and PQ as appropriate to ensure timely completion and to ensure all specifications are met.
• Prepare protocols, execute protocols, summarize data, resolve deviations, prepare final reports.
• Experience with C&Q of upstream or downstream bioprocess systems is required. Experience with C&Q of other process equipment, utilities, facilities is an asset. Thermal Validation experience is an asset.
• Coordinate meetings with cross-functional departments, to drive project progress, facilitate decisions, provide updates.
• Engage other departments, as required, for design reviews and decisions.
• Travel may be occasionally required for meetings with clients, equipment fabrication vendors or Factory Acceptance Testing (FATs).
• Work may require occasional support over shutdowns or extended hours, specifically during installation and commissioning / validation phases.
• Client-management (maintain key Client relationships in support of business development and pursuit of new work), project scheduling/budgeting, coordination of client and MMR resources for effective project delivery, supporting business development (providing technical support to the sales as required for proposals/opportunities), presenting at industry conferences/publishing papers etc.
• Visit construction and installation sites following all site safety requirements.
• Other duties as assigned by client, and/or MMR, based on workload and project requirements.

Qualifications

• Excellent written and spoken English is required including the preparation of technical documents in English
• Years of experience: 8+ years for years of experience in commissioning, qualification or validation of various systems within the pharmaceutical/biotech industry.
• Knowledge of requirements for a cGMP operations, including SOPs, Change Controls, Validation.
• Experience with developing and executing validation projects. Risk-Based Commissioning & Qualification approaches, such as ASTM E-2500 or ISPE ICQ, is considered an asset, but not required.
• Experience with commissioning and qualification of biotech process equipment (upstream or downstream or both), such as some, but not all, of the following: fermentation, bioreactors, downstream purification processes (chromatography, TFF, UF) is required
• Experience with commissioning & qualification of process control systems (i.e. PCS, SCADA, Historians) and building automation systems (i.e. Siemens Insight / Desigo, JCI Metasys) are considered an asset, but not required.
• Experience with Qualification or Validation of clean utilities, ISO clean rooms, and Thermal Validation is considered an asset.
• Experience with preparation and execution of URS’s, DQ’s, RTMs, Risk Assessments, CPPs, VPPs, FATs, SATs, IOQs, NCRs, Final Reports.
• Ability to lift 50 lbs.
• Science degree, or equivalent studies such as Mechanical, Electrical, Chemical, Biochemical, Electromechanical or a related discipline along with industry experience.
• Ability to handle multiple projects and work in a fast-paced environment.
• Strong multi-tasking skills

Compensation: 90,000$ - 145,000$ based on experience.

Equal Employment Opportunity and Reasonable Accommodations

MMR Consulting is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. Our hiring decisions are based on merit, qualifications, and business needs. We are committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please let us know the nature of your request.

Previous Pharmaceutical/Biotech experience is mandatory for this role.

MMR Consulting is an engineering and consulting firm specializing in the pharmaceutical and biotechnology industries. Its services include Engineering, Project Management, and other Consulting services.

MMR Consulting has offices in Canada, USA, and Australia.

This is an outstanding opportunity to join our growing team, where the successful candidate will work with a group of engineers and specialists involved in project management, commissioning and qualification, of equipment, systems and facilities.

This role is for CQV Engineer role to work on the commissioning, qualification, startup of upstream and downstream bioprocess systems/equipment in the biopharmaceutical industry, as well as process equipment in pharma/biotech industries.

The work will require working out of the client’s facilities in San Diego, California.

Responsibilities

• Provide technical guidance into the commissioning, qualification and start-up of various equipment and facilities used in life science manufacturing, such as bioreactors, tanks, CIP, Buffers, Media, Chrom, TFF, washers & autoclaves, centrifuges, etc.
• Lead the development of key qualification deliverables during the project lifecycle to ensure project is well defined, and the action plan to test the system is applicable and relevant.
• Lead qualification processes throughout the project lifecycle such as VPP, Risk Assessments, RTM, DQ, FAT, SAT, IQ, OQ and PQ as appropriate to ensure timely completion and to ensure all quality and engineering specifications are met.
• Prepare protocols, execute protocols, summarize data, resolve deviations, prepare final reports.
• Experience with C&Q of process equipment, utilities, facilities is an asset. Thermal Validation experience is an asset.
• Coordinate meetings with cross-functional departments, to drive project progress, facilitate decisions, provide updates.
• Engage other departments, as required, for design reviews and decisions.
• Travel may be occasionally required for meetings with clients, equipment fabrication vendors or Factory Acceptance Testing (FATs).
• Work may require occasional support over shutdowns or extended hours, specifically during installation and commissioning / validation phases.
• Client-management (maintain key Client relationships in support of business development and pursuit of new work), project scheduling/budgeting, coordination of client and MMR resources for effective project delivery, supporting business development (providing technical support to the sales as required for proposals/opportunities), presenting at industry conferences/publishing papers etc.
• Visit construction and installation sites following all site safety requirements.
• Other duties as assigned by client, and/or MMR, based on workload and project requirements.

Qualifications

• 3-6+ years for years of experience in commissioning, qualification or validation of various systems within the pharmaceutical/biotech industry.
• Engineering or Science degree, preferably in Mechanical, Electrical, Chemical, Biochemical, Electromechanical or a related discipline.
• Excellent written and spoken English is required including the preparation of technical documents in English
• Knowledge of requirements for a cGMP operations, including SOPs, Change Controls, Validation.
• Experience with developing and executing validation projects. Risk-Based Commissioning & Qualification approaches, such as ASTM E-2500 or ISPE ICQ, is considered an asset, but not required.
• Experience with commissioning and qualification of biotech process equipment (upstream or downstream or both), such as some, but not all, of the following: fermentation, bioreactors, downstream purification processes (chromatography, TFF, UF) is required
• Experience with commissioning & qualification of process control systems (i.e. PCS, SCADA, Historians) and building automation systems (i.e. Siemens Insight / Desigo, JCI Metasys) are considered an asset.
• Experience with Qualification or Validation of clean utilities, ISO clean rooms, and Thermal Validation is considered an asset.
• Experience with preparation and execution of URS’s, DQ’s, RTMs, Risk Assessments, CPPs, VPPs, FATs, SATs, IOQs, NCRs, Final Reports.
• Ability to lift 50 lbs.
• Ability to handle multiple projects and work in a fast-paced environment.
• Strong multi-tasking skills

Salary range: 80,000$ -120,000$ based on experience.

Equal Employment Opportunity and Reasonable Accommodations

MMR Consulting is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. Our hiring decisions are based on merit, qualifications, and business needs. We are committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please let us know the nature of your request.

Gretna, LA

7 month contract

Max PR: 18/hr

This position is for a night shift Mon, Tues, Wed, Sat 10pm-8:30am; however, training will occur on 1st shift Tues-Sat 6am-2:30pm until training is complete.

Must have BA in Chem or Bio

First Reviewer Position. In this role, the individual will be responsible for operating a Gas Chromatograph/Mass Spectrometer and LC-MS/MS for confirmatory testing in accordance with the SAMHSA mandatory guidelines and those of other regulatory organizations for all non-negative test results. This job also requires the individual to perform some QC duties. Must possess degree at the Bachelor level. Degree must be in biology, chemistry, or equivalent related field.

This position is Nonexempt. Hours over 40 will be paid at Time and a Half.

This position is 7:00 AM to 7:30 PM Fri/Sat/Sun or either Sat or Sun and 2 weekdays 7:00 AM- 7:30 PM.

Do you have the career opportunities as a(an) Certified Surgical Technologist you want with your current employer? We have an exciting opportunity for you to join HCA Florida Bayonet Point Hospital which is part of the nation's leading provider of healthcare services, HCA Healthcare.

HCA Florida Bayonet Point Hospital offers a total rewards package that supports the health, life, career and retirement of our colleagues. The available plans and programs include:

• Comprehensive medical coverage that covers many common services at no cost or for a low copay. Plans include prescription drug and behavioral health coverage as well as free telemedicine services and free AirMed medical transportation.
• Additional options for dental and vision benefits, life and disability coverage, flexible spending accounts, supplemental health protection plans (accident, critical illness, hospital indemnity), auto and home insurance, identity theft protection, legal counseling, long-term care coverage, moving assistance, pet insurance and more.
• Free counseling services and resources for emotional, physical and financial wellbeing
  
• 401(k) Plan with a 100% match on 3% to 9% of pay (based on years of service)
  
• Employee Stock Purchase Plan with 10% off HCA Healthcare stock
  
• Family support through fertility and family building benefits with Progyny and adoption assistance.
  
• Referral services for child, elder and pet care, home and auto repair, event planning and more
  
• Consumer discounts through Abenity and Consumer Discounts
  
• Retirement readiness, rollover assistance services and preferred banking partnerships
  
• Education assistance (tuition, student loan, certification support, dependent scholarships)
  
• Colleague recognition program
  
• Time Away From Work Program (paid time off, paid family leave, long- and short-term disability coverage and leaves of absence)
  
• Employee Health Assistance Fund that offers free employee-only coverage to full-time and part-time colleagues based on income.

Learn more about Employee Benefits

Note: Eligibility for benefits may vary by location.

Our teams are a committed, caring group of colleagues. Do you want to work as a(an) Certified Surgical Technologist where your passion for creating positive patient interactions is valued? If you are dedicated to caring for the well-being of others, this could be your next opportunity. We want your knowledge and expertise!

Certified Surgical Technologist (OR Tech)

We are currently seeking a Certified Surgical Technologist (Certified OR Tech). As a Certified Surgical or Operating Room Tech, you greet our patients, comfort them and transport them to the surgical suite. Once in the operating room, you will perform technical duties to assist in preparing and caring for our surgical patients. Apply today to join an amazing team of caring, close-knit surgical professionals!

 Typical duties may include:

• Assemble supplies and equipment needed for surgical procedures
• Prepare sterile instrument table for your procedures
• Assist in positioning patients and preparing patient’s skin for surgery
• Maintain sterile techniques and actively monitor situations that could lead to breaches in sterile technique
• Assist the surgical team during procedures which may include passing instruments, sponges and sutures
• Assist in monitoring patients
• Gather equipment for cleaning/sterilization after procedures

Qualifications

• Graduate of an approved surgical technologist program required
• Certification as a Surgical Technologist required (NCCT, NBSTSA)
• Basic Life Support (BLS) certification required
• Hospital-based OR Tech experience preferred
• Ability to perform work that requires frequent standing, bending, reaching, squatting, kneeling, moving, lifting of patients and/or equipment up to 50 pounds
• Team player attitude

HCA Florida Bayonet Point Hospital has been serving the Hudson, FL community since 1981. As a 392-bed acute care facility and designated Level II Trauma Center, we are home to the nationally acclaimed Heart Institute and employ over 350 physicians and 1,300 staff members. We were the first hospital in northwest Pasco County to offer a comprehensive cardiac and open-heart program, and our commitment to quality has earned us recognition for innovative care. Our accredited Heart Institute, Stroke Center, Chest Pain Center, and programs in Cancer Care, Orthopedics, and Neurosurgery exemplify our high-quality services. With over 100,000 procedures performed, we are dedicated to excellence.

HCA Healthcare has been recognized as one of the World’s Most Ethical Companies® by the Ethisphere Institute more than ten times. In recent years, HCA Healthcare spent an estimated $3.7 billion in costs for the delivery of charitable care, uninsured discounts, and other uncompensated expenses.

If you are looking for an opportunity that provides satisfaction and personal growth, we encourage you to apply for our Certified Surgical Technologist opening. We promptly review all applications. Highly qualified candidates will be contacted for interviews. Unlock the possibilities and apply today!

We are an equal opportunity employer. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.