Top 23617 Process Validation Engineer Jobs

Process Validation Associate / Engineer
Krystal Biotech —Pittsburgh, PA
- Full-time
- Bachelor's degree
- 1 year
- Communication skills
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Validation Engineer
VERAZ INC —Boston, MA
- $30 - $45 an hour
- Full-time
- In-person
- 1 year
- Electrical Engineering
- Relocation assistance
- Health insurance
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10d
Validation Engineer - Upstream
Validation & Engineering Group, Inc —Carolina, PR
- Extended hours
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- Mid-level
- 3 years
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Director, Mechanical & Electrical Engineering (Mechatronics)
Swisslog Healthcare —Colorado
- $135,000 - $170,000 a year
- 5 years
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- Health insurance
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Test Engineer II/III
Crane Aerospace & Electronics —Burbank, CA
- $95,700 - $138,584 a year
- Full-time
- Background check
- Bachelor of Science
- Pass drug screening
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Associate Engineer - Process Controls
Energy Transfer Partners —Marcus Hook, PA
- Weekends as needed
- System design
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Process Engineer
Gehl Food & Beverage —Lathrop, CA
- $110,000 - $130,000 a year
- Full-time
- 5 years
- Sanitation
- Master's degree
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Hardware Test Engineer
Space Information Laboratories —Santa Maria, CA
- $43 - $80 an hour
- Full-time
- Background check
- Microsoft Excel
- Microsoft Outlook
- Paid training
- Relocation assistance
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Electrical Engineer
CONTROL AUTOMATION TECHNOLOGIES INC —Puerto Rico
- $50,000 - $75,000 a year
- Full-time
- Mid-level
- Analysis skills
- Electrical Engineering
- Health insurance
- Dental insurance
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Ontology Engineer (TS/SCI)
Vantor Services Inc. —Herndon, VA
- $137,000 - $200,200 a year
- Full-time
- 11+ years
- Bachelor's degree
- Machine learning
- 401(k) matching
- Pet insurance
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TOOLING DESIGN ENGINEER
PRECISION GROUP —San Antonio, TX
- $80,000 - $85,000 a year
- Overtime
- AutoCAD
- 5 years
- Engineering
- Health savings account
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EDI Developer
Rev-A-Shelf —Louisville, KY
- From $65,000 a year
- Full-time
- Background check
- Computer Science
- ERP systems
- Health savings account
- Health insurance
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SENIOR PROCESS ENGINEER / SCIENTIFIC MOLDING ENGINEER
Moldworx LLC —Chandler, AZ
- $125,000 - $150,000 a year
- Full-time
- Engineering
- Analysis skills
- Mentoring
- Health savings account
- Paid holidays
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Lead PCB Design & Test Engineer (5228)
GVI, Inc. —San Diego, CA
- $90,000 - $150,000 a year
- Full-time
- 5 years
- Master's degree
- Continuous improvement
- Health insurance
- Dental insurance
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2d
Manufacturing Engineer II
Hamilton Medical, Inc. —Reno, NV
- $65,000 - $120,000 a year
- Full-time
- 5 years
- Research
- Mid-level
- Disability insurance
- Health insurance
Senior Process Engineer
Milwaukee Electric Tool Corporation —Mukwonago, WI
- Full-time
- 5 years
- Bachelor of Science
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Injection Molding Process Engineer / Technician (1 year experience preferred)
Midwest Molding Inc —Plain City, OH
- $70,000 - $100,000 a year
- Full-time
- ERP systems
- Mid-level
- Mentoring
- Paid holidays
- Health insurance
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High Speed Electrical Validation Engineer
Capgemini —Bellevue, WA
- $68,911 - $161,544 a year
- Full-time
- 7 years
- Senior level
- Paid holidays
- Disability insurance
Controls Systems Engineering Supervisor
Hendrickson VTG —North Canton, OH
- Full-time
- Computer Science
- Bachelor of Science
- Engineering
- Health insurance
- Dental insurance
Quick Apply
Senior Telecom Data Center Post-Sales Engineer
Netcom Technologies —Clarksburg, MD
- $130,000 - $150,000 a year
- Full-time
- Background check
- Mid-level
- Office
- Health savings account
- Health insurance
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Process Validation Associate / Engineer

Krystal Biotech -
Pittsburgh, PA

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Job Details

Full-time

Qualifications

Statistics
Statistics
ICH guidelines
Bachelor's degree
GMP for research safety and compliance
Pharmaceutical manufacturing facility experience

Full Job Description

About Krystal Bio:

At Krystal Biotech, we bring together the brightest and most eager minds to relentlessly pursue the discovery, development, manufacturing, and commercialization of genetic medicines to treat diseases with high unmet medical needs.

Founded in 2016, Krystal is distinguished in three powerful ways: science and technology using our patented gene therapy platform, innovative manufacturing supported by our commercial scale facilities, and a unique commercialization model that focuses on the patient’s end-to-end experience.

Krystal received U.S. FDA approval for the first and only redosable gene therapy treatment, VYJUVEK®, for the treatment of Dystrophic Epidermolysis Bullosa (DEB). Krystal continues to leverage our proprietary platform to rapidly advance a robust pipeline of investigational genetic medicines in respiratory, oncology, dermatology, and ophthalmology.

Krystal is headquartered in Pittsburgh, PA, which is home to our two state-of-the-art CGMP manufacturing facilities with teams around the world and satellite offices in Switzerland, Germany, and Japan. We are a company built and run by people who care, are fearless in the face of a challenge, love the work they do, and practice the highest level of scientific integrity. As we grow, we are seeking team members that embody these values.

Job Description Summary:

Krystal Biotech is seeking a highly motivated Process Validation Associate (1+ years’ experience) or Engineer (3+ years’ experience) to support process validation planning, design, and execution. This person will be responsible for risk assessments, process improvements, investigations, and other projects. They will also play a pivotal role in technology transfer and ensuring processes transition properly from site to site.

Primary Responsibilities:

Partner with Process Development and Manufacturing to ensure upstream and downstream processes are well controlled.
Apply QbD and traditional process validation principles to existing and new gene therapy products.
Perform and document risk assessments to capture existing process knowledge and to identify gaps.
Perform experiments (bench scale and manufacturing scale) to close gaps in process understanding and to support process development.
Troubleshoot process and equipment issues to help ensure efficiencies in processes.
Help implement a continuous improvement mindset to processes and departments.
Produce high-quality documentation that meets applicable standards and is appropriate for its intended use.
Work on development of new manufacturing facility to ensure proper transfer of technology and processes.
Work with CMC counterparts to draft materials intended for the agency review.

Minimum Qualifications & Desired Competencies:

Bachelors’ Degree in Chemical Engineering, Biomedical Engineering, or related
Relevant validation and/or engineering experience in the Biotech or Pharmaceutical industry (1+ yr for Associate, 3+ yr for Engineer level)
Background that includes knowledge/experience in GMP, GLP, and statistics
Strong knowledge of GMP and ICH requirements and QbD
Prior experience in the gene therapy field is desired
Must be a self-starter and capable of working with minimal oversight
Must be able to handle multiple roles and work in a fast paced and changing environment and know how to prioritize activities appropriately
Excellent oral and written communication skills

Krystal Biotech, Inc. is an Equal Employment Opportunity and Affirmative Action Employers. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender perception or identity, national origin, age, marital status, protected veteran status, or disability status. Headhunters and recruitment agencies may not submit resumes/CVs through this Web site or directly to managers. Krystal Biotech, Inc. does not accept unsolicited headhunter and agency resumes. Krystal Biotech, Inc. will not pay fees to any third-party agency or company that does not have a signed agreement with Krystal Biotech, Inc.
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Refine Your Search

Process Validation Engineer jobs

Process Validation Associate / Engineer

Validation Engineer

Validation Engineer - Upstream

Director, Mechanical & Electrical Engineering (Mechatronics)

Test Engineer II/III

Associate Engineer - Process Controls

Process Engineer

Hardware Test Engineer

Electrical Engineer

Ontology Engineer (TS/SCI)

TOOLING DESIGN ENGINEER

EDI Developer

SENIOR PROCESS ENGINEER / SCIENTIFIC MOLDING ENGINEER

Lead PCB Design & Test Engineer (5228)

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Senior Process Engineer

Injection Molding Process Engineer / Technician (1 year experience preferred)

High Speed Electrical Validation Engineer

Controls Systems Engineering Supervisor

Senior Telecom Data Center Post-Sales Engineer

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