Top 25816 Process Validation Engineer Jobs

Process Engineer
Piramal Pharma Solutions —Lexington, KY
- $69,000 - $96,000 a year
- Full-time
- Background check
- Microsoft Excel
- 5 years
- Health savings account
- Health insurance
Quick Apply
Process Engineer
Zentis North America —Plymouth, IN
- Bachelor of Science
- Mid-level
- Windows
Manufacturing Process Engineer
Piramal Pharma Solutions —Lexington, KY
- Up to $100,000 a year
- Full-time
- Background check
- Maintenance
- Research
- Health savings account
- Health insurance
Quick Apply
Product & Process Engineer
UGN, Inc. —Somerset, KY
- Hybrid work
- Microsoft Excel
- Microsoft Outlook
- Up to 50% travel
Quick Apply
Validation Engineer (OPT/CPT)
Validation Associates LLC —Herndon, VA
- $30 - $33 an hour
- Contract
- Engineering
- Mid-level
- Analysis skills
- Relocation assistance
- Health insurance
Quick Apply
10d
Process Validation Engineer
Katalyst Healthcares & Life Sciences —Indianapolis, IN
- Contract
- Hybrid work
- Engineering
- Mid-level
- Communication skills
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Process Validation Associate / Engineer
Krystal Biotech —Pittsburgh, PA
- Full-time
- Bachelor's degree
- 1 year
- Communication skills
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Process Validation Engineer
AVEVA DRUG DELIVERY SYSTEMS INC —Miramar, FL
- $90,000 - $110,000 a year
- PMP
- 5 years
- Mid-level
Senior IT Construction Engineer, NA
Vantage Data Centers Management Company LLC —Port Washington, WI
- $106,000 - $115,000 a year
- Full-time
- Background check
- Computer science
- Computer Science
- AD&D insurance
- Disability insurance
Quick Apply
13d
Acquisition Program Analyst / Systems Engineer
A² Systems Engineering —El Segundo, CA
- $170,000 - $200,000 a year
- Full-time
- Engineering
- In-person
- Senior level
- Paid jury duty
- AD&D insurance
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
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
- Paid holidays
- Disability insurance
Facilities & Utilities Engineer
Sabinsa Corporation —Payson, UT
- $55,000 - $60,000 a year
- Full-time
- Continuous improvement
- HVAC
- In-person
Quick Apply
Process Automation Engineer (Manufacturing)
Heraeus Incorporated —Chandler, AZ
- Full-time
- Background check
- Mid-level
- 3 years
- Health savings account
- Health insurance
Quick Apply
2d
Optics Engineer
Confidential Posting —San Francisco, CA
- $110,000 - $160,000 a year
- Full-time
- Travel
- US work authorization
- In-person
- Health insurance
- Dental insurance
Quick Apply
Senior Staff Electrical Engineer
AED, Inc —Bozeman, MT
- $200,000 - $240,000 a year
- Full-time
- Background check
- Research
- Bachelor's degree
- Health savings account
- AD&D insurance
Quick Apply
Staff Engineer, CAE Simulation and Analysis
Bergstrom Inc —Rockford, IL
- $80,000 - $120,000 a year
- Full-time
- 5 years
- Engineering
- Master's degree
- Health insurance
- Dental insurance
Quick Apply
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
Quick Apply
Project Design Engineer
Optronics International, LLC —Tulsa, OK
- Full-time
- Background check
- Microsoft Excel
- Microsoft Outlook
Quick Apply
Director of Engineering
Tribotech Composites Inc —Cleveland, OH
- $100,000 - $120,000 a year
- Full-time
- Background check
- Office
- Fair chance
- Health insurance
- Dental insurance
Quick Apply

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Process Engineer

Piramal Pharma Solutions -
Lexington, KY

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Job Details

Full-time
$69,000 - $96,000 a year

Benefits

Health savings account
Health insurance
Dental insurance
401(k)
Flexible spending account
Tuition reimbursement
Paid time off
Parental leave
Employee assistance program
Vision insurance
401(k) matching
Life insurance
Referral program
Retirement plan

Qualifications

Incident investigation techniques for hazard identification
Microsoft Excel
Defect resolution root cause analysis
Chemical Engineering
Pharmaceutical regulatory compliance
Production risk assessment
Chemical scale-up projects
Manufacturing facility experience
Bachelor's degree in engineering
Production validation processes
Bachelor's degree
Pharmaceutical company experience
Technology transfer (scale-up process)
Collaboration with manufacturing teams
Biomedical regulatory compliance
Productivity software
Sterile products production
Cross-functional team management
Chemical engineering
Cross-functional communication
FDA regulations
Failure analysis
Pharmaceutical manufacturing facility experience

Full Job Description

Company Overview
Piramal Pharma Solutions (PPS) is a dynamic Contract Development and Manufacturing Organization (CDMO) that provides comprehensive drug development and manufacturing services across the entire pharmaceutical lifecycle. Our globally integrated network of facilities enables us to deliver innovative solutions to our clients worldwide, including drug discovery, process development, clinical supply, and commercial manufacturing of APIs and finished dosage forms.

Job Overview

Reporting to the Technical Services Manager, the Process Engineer works to design and efficiently transfer new processes into manufacturing, optimize existing processes, ensuring the achievement of quality, yield, and capacity timelines.

Reporting Structure

This position reports to the Technical Services Manager

Key Responsibilities:

Drafts experimental, development, and operational studies to expand expertise in parenteral manufacturing.
Ensures that work is performed in an accurate, timely, and efficient manner, and in compliance with company policies, SOPs, cGMP regulations, and FDA regulations.
Contributes to resolving deviations, investigations and continuous improvements to improve processes, quality, costs, safety and/or cycle time.
Interfaces with Operations, Validation, Quality Assurance groups and Formulation Development to identify new components and/or processes into the existing manufacturing environment.
Take initiative to develop and improve procedures and setups through the change control process.
Prepares and reviews technical documents to include but not limited to: Technical Reports, SOP's, Master Batch Records (MBR's), Change Controls, Cost Quotes, Product and Process Verification/Validation Protocols.
Contributes to investigations and deviations related to manufacturing, defines root causes and implements corrective actions.
Troubleshoots and investigates manufacturing problems, monitors the processes and optimizes processes as required.
Maintains awareness of current developments in the functional discipline
Reviews current and new processes; applies state-of-the art technology to our processes
Coordinate line activities with other functions such as maintenance and downstream manufacturing events.
Recommends, justifies, demonstrates and implements new manufacturing technologies as they become available.
Maintains documentation on all projects and submit written reports in a timely fashion.
Interfaces with other operating units within and outside the department. Presents ideas and suggestions for product and/or process, equipment improvements, improved Laboratory and Manufacturing operations.
Train Manufacturing staff on new processes and/or equipment technologies, as needed
Interacts with external vendors.
Independently plan and organize non-routine tasks. Initiates and maintains work schedule. Follow-through on priorities of work assignments.
Exercises judgment in selecting innovative, practical methods to achieve problem resolution.

Qualifications:

Bachelor degree in Mechanical, Biological, or Chemical Engineering
5+ years of experience working within pharmaceutical manufacturing/development environment, process development and scale-up, contract manufacturing strongly preferred
Experience working within aseptic or lyophilization manufacturing
Knowledge and understanding of cGMPs validation requirements and techniques.
Knowledge and experience in cGMP CA/PA, root-cause analysis, risk assessment and investigation tools and techniques
Knowledge and understanding of the regulatory approval process for US, EU, and JP
In-depth knowledge of pharmaceutical parenteral manufacturing principles and packaging equipment
Working knowledge of lyophilized and aseptic product validation is desirable
Ability work within and lead a cross-functional team which may include operations, quality assurance, validation, and laboratory personnel
Good oral and written communication skills
Able to handle multiple complex tasks and set priorities with multiple internal customers
Proficiency using Microsoft Office applications (Word, Excel, PowerPoint)
Bachelor of Engineering (BE)

Pay: $69,000.00 - $96,000.00 per year

Benefits:

401(k)
401(k) matching
Dental insurance
Employee assistance program
Flexible spending account
Health insurance
Health savings account
Life insurance
Paid time off
Parental leave
Referral program
Retirement plan
Tuition reimbursement
Vision insurance

Work Location: In person

Quick Apply

Refine Your Search

Process Validation Engineer jobs

Process Engineer

Process Engineer

Manufacturing Process Engineer

Product & Process Engineer

Validation Engineer (OPT/CPT)

Process Validation Engineer

Process Validation Associate / Engineer

Process Validation Engineer

Senior IT Construction Engineer, NA

Acquisition Program Analyst / Systems Engineer

Manufacturing Engineer II

Test Engineer II/III

Facilities & Utilities Engineer

Process Automation Engineer (Manufacturing)

Optics Engineer

Senior Staff Electrical Engineer

Staff Engineer, CAE Simulation and Analysis

SENIOR PROCESS ENGINEER / SCIENTIFIC MOLDING ENGINEER

Project Design Engineer

Director of Engineering

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