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Added 3 mins ago
MES Engineer IT Systems
Bristol Myers Squibb
Bothell, WA
…specific expertise in Manufacturing, Quality, and Supply Chain systems and in Computer System Validation (CSV). Hands-on Breyanzi process knowledge is a strong advantage, and eMES…
Added 3 mins ago
RF System Engineer, Amazon Leo
Amazon
Redmond, WA
As a Sr. RF Systems Analysis and Design Engineer, you will own end-to-end modeling and performance analysis of complex satellite links and RF sub-system design, spanning modem, RF…
Added 3 mins ago
Sr. Manufacturing Automation Engineer, Amazon Leo
Amazon
Redmond, WA
As a Sr. Manufacturing Automation Engineer, you will lead the development of custom automation, production stations, engineering fixtures, and test systems for battery pack manufacturing.…
Added 3 mins ago
Sr Avionics Lab Engineer, EE Avionics PCBA Rework
Amazon
Redmond, WA
The Role: The Sr Avionics Lab Engineer role will be part of the electrical engineering hardware development team designing Amazon Leo's satellite electronic sub-systems. Successful…
Added 3 mins ago
Software Dev Engineer, Antenna System Validation
Amazon
Redmond, WA
As a Software Development Engineer on antenna systems validation team, you'll build the software backbone that powers our satellite ground infrastructure. You'll work at the intersection of…
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Senior Software Development Engineer , Leo Customer Terminals Applications & Networking Team
Amazon
Redmond, WA
…self-diagnosing internet gateway. As a Software Development Engineer II on this team, you will design and build software that operates on customer terminals deployed in the field at large…
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Hardware Development Engineer II, AWS Mainstream Compute
Amazon
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7+ years of server, storage, networking, or large-scale distributed systems experience
Added 4 mins ago
Software Development Manager, Elastic Kubernetes Service (EKS)
Amazon
Seattle, WA
Raise release velocity for add-on partner teams while tightening the safety envelope: staged rollouts, bake time, automated validation, fast rollback
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Senior Mgr. Engineering Certification , Prime Air - Office of the Chief Engineer
Amazon
Seattle, WA
Own the certification compliance strategy for Prime Air's unmanned aircraft systems across DO-178C (software), DO-254 (hardware), and DO-160G (environmental qualification), identifying…
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Staff Software Engineer, Geo Automotive SDK
Google
Seattle, WA
Share Staff Software Engineer, Geo Automotive SDK
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Sr.Software Dev Engineer, DDB Index and Search
Amazon
Seattle, WA
As an SDE III, you will own significant technical decisions and carry them through implementation, validation, launch, and production operation. You will lead designs spanning component…
Added 4 mins ago
Data Analyst 3 - Insights Delivery Merchandising Analytics
Nordstrom
Seattle, WA
Use AI tools to accelerate requirements discovery, understanding of systems and data, and the development and review of data pipelines and reports.
Added 4 mins ago
Senior Data Engineer (Online Data)
Zoom
Seattle, WA
…senior individual contributor role reporting into the Data Systems and Online Technology organization. This is a hybrid position that requires on-site presence three (3) days per week at…
Added 4 mins ago
PW
Lead Software Engineer - Validation Solutions, Automation & Analytics
Paccar Winch Inc.
Mount Vernon, WA
- $104,100 to $162,900 USD / year
The Validation team at the PACCAR Technical Center is seeking a hands-on Lead Software Engineer to develop software and data solutions that improve validation efficiency, consistency, and…
Added 6 mins ago
CMM Programming and Metrology Engineer
Williams International
Ogden, UT
The Opportunity - Williams International has an exciting opportunity for a CMM Programming and Metrology Engineer at our facility located at 3450 Sam Williams Dr., Ogden, UT 84401. The…
Added 8 mins ago
Electrical Engineer I (For SNC Summer 2026 Interns Only)
Sierra Nevada Corporation
Plano, TX
…humanity through technology and imagination! As an Electrical Engineer I, you will be involved in the initial phases of research, design, and development of electrical/electronic systems…
Added 9 mins ago
Mechanical Design Engineer
Actalent
Mentor, OH
Job DescriptionThe Mechanical Design Engineer role leads the end-to-end development of heavy-duty truck accessories and systems for commercial and vocational truck platforms. You will focus…
Added 9 mins ago
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Design Quality Engineer
Actalent
Warsaw, IN
- $45 to $54 USD / hour
Job Title: Design Quality EngineerJob DescriptionThe Design Quality Engineer serves as a highly engaged quality partner to research and development teams across new product development and…
Added 9 mins ago
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Validation Engineer
Actalent
Saint Paul, MN
- $40 to $52 USD / hour
DescriptionThe Validation Engineer will be responsible for preparing and executing commissioning, qualification, and validations for new processes, materials, equipment, cleaning, and…
Added 9 mins ago
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Manufacturing Engineer
Actalent
Brooklyn Park, MN
- $48 to $60 USD / hour
Job Title: Manufacturing EngineerJob DescriptionThis Manufacturing Engineer role focuses on supporting the production of commercial and non-commercial finished medical devices, with primary…
Added 9 mins ago
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Test Engineer
Actalent
Burnsville, MN
- $38 to $47 USD / hour
Job Title: Test EngineerJob DescriptionThe Test Engineer performs end-to-end test engineering activities across all product test stages, from requirements definition and test planning to…
Added 9 mins ago
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Quality Engineer III - Process Validation
Actalent
Saint Louis, MO
- $36 to $48 USD / hour
Job Title: Quality Engineer IIIJob DescriptionAs a Quality Engineer III (QE III), you will play a critical role in supporting quality activities across the product lifecyclefrom New Product…
Added 13 mins ago
AI Enablement Engineer
Revalize
Remote, United States
Help develop LLM pipelines: retrieval, structured data extraction, scoring logic, prompt and tool design, and validation of outputs before they touch business systems
Added 13 mins ago
Reliability Test Engineer
Base Power Company
Austin, TX
Base is hiring a Reliability Test Engineer to find the limits of our hardware before the field does. You'll design and build test setups, automate them, run electrical, mechanical, and…
Added 15 mins ago
Senior Cyber Security Engineer
L3Harris Technologies
Columbia, MD · Rochester, NY
Job Title: Senior Specialist, Information Security Systems Engineer

Syner-G

Project Engineer

Gaithersburg, MD, United States

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Job details

Experience: 3+ years of CQV, Validation, Engineering, or Technical Operations experience within biotechnology, pharmaceutical, or other GMP-regulated manufacturing environments.
Posting language: English
Posted: Nov 6, 2026

Original job description

COMPANY DESCRIPTION:

A career here is life-enhancing.

At Syner-G, we enable our people to build careers that impact positively on their quality of life. Through our expertise, insight, consulting and management skills, we accelerate breakthrough science and delivery of life-enhancing therapies to more patients. We work across a diverse range of clients and projects, supporting many organizations from the most critical phases of the drug discovery and approval process through to commercialization. It is meaningful, varied and thought-provoking work with a strategic emphasis, a solutions-driven approach and significant, real-world outcomes, from science to delivery/success. To learn more about who we are and what drives us, watch our company video here.

Underpinning this mission is a culture that aligns perfectly with what we want to achieve. We enable our people to grow, we support them in their learning and we reward them in so many different ways. In return, they play an instrumental role in maintaining our reputation across the globe as a strategic biopharma product development and delivery partner.

Syner-G was recently honored with BioSpace's prestigious "Best Places to Work" 2026 award, for the third consecutive year, along with many other award-winning programs to make a career here truly life-enhancing. These recognitions are a testament to our commitment to fostering a positive and engaging work environment for our employees, with a particular emphasis on culture, career growth and development opportunities, financial rewards, leadership and innovation.

At Syner-G, we recognize that our team members are our most valuable asset. Join us in shaping the future, where your talents are valued, and your contributions make a meaningful impact.

For more information, visit www.Synergbiopharma.com

POSITION OVERVIEW:

We are seeking experienced Project Engineers to support commissioning and qualification activities within GMP-regulated biopharmaceutical manufacturing environments. This role will primarily focus on the development, execution, and documentation of Installation Qualification (IQ) protocols for bioreactors, media hold tanks, and associated process systems. The ideal candidate will possess hands-on CQV experience and a strong understanding of equipment qualification, engineering documentation, and GMP compliance requirements.

WORK LOCATION:

Travel to client sites may be required up to 100%, depending on project needs and client expectations.

KEY RESPONSIBILITIES:

(This list is not exhaustive and may be supplemented or adjusted as needed.)

Develop, review, and execute Installation Qualification (IQ) protocols for bioreactors, media hold tanks, and associated process equipment.
Verify equipment installation against approved P&IDs, engineering specifications, vendor documentation, and design drawings.
Perform field walkdowns, equipment inspections, and installation verification activities to ensure compliance with project and regulatory requirements.
Confirm proper installation and identification of instrumentation, utilities, piping components, and process equipment.
Review vendor turnover packages, material certifications, calibration records, equipment manuals, and supporting qualification documentation.
Identify, document, and support resolution of qualification discrepancies, punch list items, and deviations.
Collaborate with Engineering, Manufacturing, Quality Assurance, Validation, and equipment vendors to support system turnover and qualification readiness.
Support commissioning and qualification activities in accordance with GMP, GDP, and site validation procedures.
Maintain accurate and complete qualification documentation to support regulatory inspections and audits.
Communicate project status, execution risks, and qualification progress to stakeholders and project teams.
Ensure all work is performed in compliance with site safety standards, quality requirements, and regulatory expectations.

QUALIFICATIONS AND REQUIREMENTS

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Education

Bachelor's Degree in Engineering, Life Sciences, Biotechnology, or a related technical discipline.

Technical Experience

3+ years of CQV, Validation, Engineering, or Technical Operations experience within biotechnology, pharmaceutical, or other GMP-regulated manufacturing environments.
Demonstrated experience developing and executing IQ protocols for process equipment.
Experience qualifying bioprocess equipment such as bioreactors, media preparation systems, media hold tanks, process vessels, and associated utility systems.
Experience reviewing engineering documentation including P&IDs, equipment specifications, vendor packages, and turnover documentation.
Familiarity with commissioning, qualification, and validation lifecycle activities.
Working knowledge of GMP documentation practices, Good Documentation Practices (GDP), and regulatory compliance requirements.
Experience utilizing electronic validation systems such as Kneat or similar validation platforms is preferred.

Knowledge, Skills, and Abilities

Strong understanding of CQV methodologies and equipment qualification principles.
Knowledge of upstream bioprocess manufacturing systems and related equipment.
Ability to interpret engineering drawings, P&IDs, and technical documentation.
Strong technical writing, documentation, and organizational skills.
Ability to manage multiple priorities in a fast-paced project environment.
Strong analytical and problem-solving abilities with a high attention to detail.
Excellent verbal and written communication skills.
Ability to work independently and collaboratively within cross-functional teams.

ESSENTIAL FUNCTIONS:

Physical Demands:

The physical demands described here are representative of the requirements that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to use a computer keyboard and mouse; reach with hands and arms; talk and listen. The employee is frequently required to walk and sit, as well as to lift and carry objects such as books and files weighing up to 25 pounds. The employee is occasionally required to stand, stoop, or kneel. Specific vision abilities required by this position include close vision and the ability to adjust focus.

Work Environment:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job, including moderate noise level, an indoor temperate environment, and light levels that are bright and conducive to minimal eye strain, typical for an office environment.

TOTAL REWARDS PROGRAM:

We define total rewards as compensation, benefits, remote work/flexibility, development, recognition, and our culture with programs that support each of our reward pillars. This includes a market competitive base salary and annual incentive plan, robust benefit offerings, and ongoing recognition and career development opportunities. Employees also enjoy our generous flexible paid time off program, company-paid holidays, flexible working hours, and fully remote work options for most positions and the ability to work “almost anywhere.” However, if a physical work location is more for you, we have office locations in Greater Boston; San Diego, CA; Boulder, CO; and India.

Currently, Syner-G is unable to sponsor or take over sponsorship of an employment Visa at this time.

LEGAL STATEMENT: Syner-G is proud to be an Equal Employment Opportunity and Affirmative Action employer. All employment decisions, including the recruiting, hiring, placement, training availability, promotion, compensation, evaluation, disciplinary actions, and termination of employment (if necessary) are made without regard to the employee’s race, color, creed, religion, sex, pregnancy or childbirth, personal appearance, family responsibilities, sexual orientation or preference, gender identity, political affiliation, source of income, place of residence, national or ethnic origin, ancestry, age, marital status, military veteran status, unfavorable discharge from military service, physical or mental disability, or on any other basis prohibited by applicable law. Syner-G is an E-Verify employer.

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