Top 127 Systems engineer iv Jobs in Poolesville, Md

MSAT Bioprocess Engineer III / IV
Theradaptive —Frederick, MD
- $108,000 - $139,000 a year
- Engineering
- Travel
- In-person
4d
Validation Engineer IV
Quality Agents —Rockville, MD
- Full-time
- 7 years
- Microsoft Excel
- Bachelor of Science
- Health savings account
- AD&D insurance
Quick Apply
Engineer Electrical Level 4 - Power Subsystems - Dulles
Northrop Grumman —Dulles, VA
- $142,200 - $213,400 a year
- Overtime
- Customer service
- 5 years
- Travel
- Paid holidays
- Disability insurance
4d
Engineer Electrical Level 4 - Power Subsystems - Dulles
Northrop Grumman —McLean, VA
- $142,200 - $213,400 a year
- Overtime
- Customer service
- 5 years
- Travel
- Paid holidays
- Disability insurance
4d
Systems Engineer III-VI
X energy LLC —Rockville, MD
- $120,000 - $215,000 a year
- Full-time
- Engineering
- Office
- Doctor of Philosophy
- Disability insurance
- Health insurance
Systems Engineer IV
Arcfield —Chantilly, VA
- $110,204.91 - $191,624.96 a year
- Full-time
- 5 years
- Bachelor of Science
- Business development
- Paid holidays
- Disability insurance
Microreactor System Engineer III-IV
X energy LLC —Rockville, MD
- $120,000 - $170,000 a year
- Full-time
- Engineering
- Office
- Doctor of Philosophy
- Disability insurance
- Health insurance
Mechanical Engineer (Engineer IV)
Fairfax County Government —Fairfax, VA
- $88,765.46 - $155,339.60 a year
- Full-time
- Construction site
- Writing skills
- Engineering
- Health insurance
- Dental insurance
10d
Engineer IV, Cybersecurity
X energy LLC —Rockville, MD
- $180,000 - $205,000 a year
- Full-time
- Hybrid work
- Azure
- High school diploma or GED
- AWS
- Disability insurance
- Health insurance
Systems Engineer IV
Kapsch TrafficCom USA Inc. —McLean, VA
- Full-time
- Background check
- 7 years
- Azure
- Paid holidays
- Health insurance
Quick Apply
12d
Software Engineer IV, Artificial Intelligence
X energy LLC —Rockville, MD
- $144,000 - $192,000 a year
- Full-time
- Computer Science
- Research
- Office
- Disability insurance
- Health insurance
Engineer IV, Cell Typing Scientist
CEDENT —Rockville, MD
- 5 years
- Engineering
- Analysis skills
Test Systems Design Lead
X energy LLC —Rockville, MD
- $112,275 - $210,750 a year
- Full-time
- Ability to walk for extended periods
- Engineering
- Doctor of Philosophy
- Disability insurance
- Health insurance
Systems Engineer IV
Farfield Systems, Inc —Arlington, VA
- Full-time
- Computer science
- Computer Science
- DevOps
7d
Nuclear Engineer, IV
X energy LLC —Rockville, MD
- $155,000 - $185,000 a year
- Full-time
- Management
- Engineering
- Office
- Disability insurance
- Health insurance
Mechanical Engineer, Graphite
X energy LLC —Rockville, MD
- $95,000 - $170,000 a year
- Full-time
- Engineering
- Research
- Office
- Disability insurance
- Health insurance
Engineer IV, Mechanical
Meso Scale Diagnostics, LLC. —Gaithersburg, MD
- $116,600 - $177,800 a year
- Hybrid work
- Office
- Master's degree
- Assembly
- Paid parental leave
- AD&D insurance
Quick Apply
Senior Technical Advisor for Materials Engineering
US Nuclear Regulatory Commission —Rockville, MD
- $151,661 - $209,600 a year
- Part-time
- Background check
- Management
- Bachelor of Science
- Commuter assistance
- Paid holidays
10d
Systems Engineer- MECM
Indigo IT —Ashburn, VA
- $80,000 - $90,000 a year
- Mid-level
- 3 years
- Analysis skills
- Paid holidays
- Health insurance
Quick Apply
Mechanical Design Engineer
X energy LLC —Rockville, MD
- $95,000 - $170,000 a year
- Full-time
- Engineering
- Research
- Office
- Disability insurance
- Health insurance

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systems engineer iv jobs near poolesville, md

MSAT Bioprocess Engineer III / IV

Theradaptive -
Frederick, MD

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Job Details

$108,000 - $139,000 a year
4 days ago

Qualifications

Technical engineering
Document control experience within pharmaceutical industry
Quality control statistical data analysis
Statistical Process Control
Production deviation management
Corrective and preventive actions (CAPA)
GMP
Cleanroom protocols
Internal investigations
Personal protective equipment (PPE) adherence
Statistical analysis
Production validation processes
Cleanroom gowning procedures
ICH Q10
Bioprocessing
Biomedical regulatory compliance
Cross-functional communication
Pharmaceutical manufacturing facility experience

Full Job Description

Theradaptive is revolutionizing the field of therapeutic delivery with a pipeline of best-in-class products that address multiple global markets. Theradaptive is performing cutting edge science in the area of regenerative medicine, working at the interface of biology and tissue repair.

Our lead therapeutics are in the following indications:

Spinal Fusion
Long Bone Repair
Osteochondral Repair
Dental and Facial Bone Repair
Immuno-Oncology

We are an innovative, fast-paced team that is advancing a diverse array of cutting-edge translational research projects.

POSITION SUMMARY

Theradaptive is seeking a skilled and driven MSAT Process Engineer III/IV to join our Manufacturing Science and Technology team. This role will provide hands-on technical leadership and manufacturing support for GMP operations, lead deviation investigations and CAPA activities, support process validation and continued process verification (CPV), and partner cross-functionally to advance Theradaptive’s combination product pipeline. The successful candidate will bring strong technical judgment, a data-driven approach to problem solving, and the ability to translate process knowledge into robust, compliant, and scalable manufacturing solutions.

Travel requirement: Up to 10%, primarily to support CMO/CDMO technology transfer activities.

RESPONSIBILITIES

GMP Manufacturing Support

Serve as the primary technical point of contact for day-to-day GMP manufacturing operations.
Monitor real-time manufacturing activities, troubleshoot process issues, and drive timely resolution of technical challenges.
Ensure manufacturing processes remain continuously aligned with cGMP requirements and applicable regulatory expectations.

Deviation Management & Investigations

Lead and independently author deviation investigations, applying structured root cause analysis (RCA) methodologies (e.g., 5-Why, Fishbone, FTA).
Develop and track robust CAPA plans; assess effectiveness and drive closure in a compliant and timely manner.
Manage change control activities, evaluating technical impact and ensuring thorough documentation.

Process Validation & Continued Process Verification (CPV)

Own and execute process validation activities including Process Performance Qualification (PPQ) protocols and reports.
Apply Design of Experiments (DOE) principles to support process characterization, parameter optimization, validation strategy, and establishment of robust process control ranges.
Analyze CPV metrics and process datasets to proactively identify trends, risks, and opportunities for improvement.
Support product lifecycle management and post-approval change activities.

Technology Transfer

Lead or support technology transfer activities between process development, internal GMP manufacturing, and external contract manufacturing organizations (CMOs/CDMOs).
Author and review technology transfer plans, batch records, and technical reports to ensure manufacturing readiness.
Drive process scale-up and process improvement activities by translating development-scale processes into robust, scalable, and GMP-ready manufacturing operations.

GMP Documentation

Author, review, and approve GMP documentation including deviations, technical reports, validation protocols/reports, change controls, and SOPs.
Maintain high documentation standards consistent with regulatory expectations and internal quality systems.

Cross-Functional Collaboration & Continuous Improvement

Partner cross-functionally with Manufacturing, QC, QA, Supply Chain, and Regulatory teams to drive compliant, efficient operations.
Champion continuous improvement initiatives and apply process excellence principles to manufacturing performance.
Participate in audit and inspection readiness activities, including preparation of technical summaries and subject-matter expert support.

QUALIFICATIONS

Bachelor’s or master’s degree in engineering, Biotechnology, Biochemistry, Pharmaceutical Sciences, or a related scientific field.
Minimum 4–8 years of progressive experience in MSAT, Bio process engineering, or process development, GMP manufacturing support in biologics or medical devices,
Demonstrated ability to independently lead deviation investigations, CAPA development, and change control activities.
Hands-on experience with process validation (PV), Process Performance Qualification (PPQ) and CPV programs.
Prior involvement in technology transfer activities, including transfers to or from CMO/CDMO partners, preferred.
Working knowledge of biologics unit operations, including one or more of the following:
Cell culture (mammalian, microbial, or primary cell systems)
Downstream purification (chromatography, filtration, centrifugation)
Formulation and fill-finish operations
Experience with statistical data analysis, SPC charting, and process trending tools.
Familiarity with regulatory frameworks including FDA 21 CFR Part 211/600, ICH Q8/Q9/Q10, and ISO standards.
Proficiency with GMP documentation systems (electronic or paper-based) and quality management systems (e.g., Track Wise, Master Control).
Data-driven problem solver with strong scientific judgment.
Clear technical communicator and cross-functional collaborator.
Detail-oriented, accountable, adaptable, and improvement-minded.

PHYSICAL DEMANDS

Ability to work in classified cleanroom environments and meet all applicable gowning and PPE requirements.
Capacity to stand for extended periods and perform repetitive technical tasks in a GMP setting.
Ability to lift and handle laboratory equipment and supplies as required.

COMPENSATION RANGE:
$108,000-$139,000 annually, based on qualifications and level.

POSITION LOCATION:
On-site at Theradaptive's corporate headquarters in Frederick, MD.

https://www.theradaptive.com 

Theradaptive is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, ethnic or national origin, ancestry, pregnancy (including childbirth or related condition), citizenship, familial status, mental or

Apply Now

Refine Your Search

systems engineer iv jobs in poolesville, md

MSAT Bioprocess Engineer III / IV

Validation Engineer IV

Engineer Electrical Level 4 - Power Subsystems - Dulles

Engineer Electrical Level 4 - Power Subsystems - Dulles

Systems Engineer III-VI

Systems Engineer IV

Microreactor System Engineer III-IV

Mechanical Engineer (Engineer IV)

Engineer IV, Cybersecurity

Systems Engineer IV

Software Engineer IV, Artificial Intelligence

Engineer IV, Cell Typing Scientist

Test Systems Design Lead

Systems Engineer IV

Nuclear Engineer, IV

Mechanical Engineer, Graphite

Engineer IV, Mechanical

Senior Technical Advisor for Materials Engineering

Systems Engineer- MECM

Mechanical Design Engineer

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