Apply Now

Process Engineer

Morristown, NJ, US • Posted 60+ days ago • Updated 11 hours ago

Full Time

On-site

Fitment

Dice Job Match Score™

🔢 Crunching numbers...

Job Details

Skills

Technical Support
GMP
Management
Data Collection
CMOS
Collaboration
Regulatory Compliance
Problem Solving
Conflict Resolution
Science
Pharmacy
Chemistry
IT Operations
IT Service Management
Microsoft Excel
Microsoft PowerPoint
Good Manufacturing Practice
Pharmaceutics
API
Manufacturing
Analytical Skill
Root Cause Analysis
Process Engineering
Productivity
Cost-benefit Analysis
Evaluation

Summary

Responsibilities:

Provide technical support for all products manufactured externally at third party contract manufacturers, North American locations. Frequent visits to third party sites for batch monitoring are required.
ct as the technical expert on all product formulations, scale-up activity, process validation, equipment qualification, process related technical issues and investigations to ensure sites adhere to GMP and regulatory guidelines.
Review and/or author technical protocols, reports or memos.
Lead Continued Process Verification (CPV) activities across Contract Manufacturing Organizations (CMOs).
This includes overseeing data collection and analysis, ensuring ongoing process performance and control, partnering with CMOs to identify and mitigate risks, and driving continuous improvements to strengthen product robustness.
The role will collaborate closely with Quality, MSAT, and CMO technical teams to ensure compliance with regulatory expectations and maintain a state of control throughout the product lifecycle.
Support manufacturing tech transfer of new and existing products.
Support multi-functional teams to formulate plans and strategy that meet defined objectives.
Troubleshoot manufacturing issues, conduct effective problem-solving and provide solutions leading to product releases.
Review, execute and support validation activities at third party contractors.
Work with Regulatory teams as needed to support product submissions to the FDA.

Requirements:

Bachelor of Science, Pharmacy, Engineering, or Chemistry.
8 to 10+ years in Pharmaceutical Operations or Technical Operations with the application of cGMPs in the Pharmaceutical or related regulated industry.
10+ years in a Technical Services or engineering function.
Experience in third party manufacturing, technical services support function and plant operations.
Good knowledge and hands-on application of Word, Excel, and Powerpoint are necessary.

Skills:

Thorough knowledge of cGMP's and regulatory requirements with respect to development, engineering and validation of pharma products.
Comprehensive knowledge of drug product manufacturing for solid and liquid oral dosages. Knowledge of API manufacturing a plus.
bility to work in cross functional teams, provide strong analytical skills for troubleshooting and root cause analysis, and communicate with internal and external team members.
Knowledge of product manufacture, formulation, quality, FDA and EMA regulations, technical transfer, process development and validation.
Skilled in improving productivity, cost analysis, and plant equipment evaluation.

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.

Dice Id: 91116760
Position Id: 5be7aaab55a7e010dcfe654cd19ee0b8
Posted 30+ days ago

Create job alert

Never miss an opportunity! Create an alert based on the job you applied for.

Similar Jobs

Specialist, Engineering (Onsite)

Rahway, New Jersey

•

Today

Job Description Non-Sterile Specialist, Engineering Position Summary This Engineer position provides on-site engineering support for the Rahway, NJ FLEx (Formulation, Laboratory & Experimentation) center, supporting non-sterile operations within Our Company's Research Labs Pharmaceutical Sciences (Pharm Sci), Pharmaceutical Operations Engineering group (Pharm Ops Engineering). Off-shift (2nd shift), Monday through Friday, is required to meet operational needs. The FLEx facility supports form

Full-time

USD 87,300.00 - 137,400.00 per year

Senior Engineer I, Drug Product Process Engineer (Hopewell, NJ)

Hopewell, New Jersey

•

Today

BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer. General Description: BeOne Medicines is seeking a highly motivated and organized Drug Product Process Engineer to join our team at the Hopewell, NJ site. The successful candidate will be resp

Full-time

USD 109,900.00 - 149,900.00 per year

Senior Engineer I, Site Automation (Hopewell, NJ)

Hopewell, New Jersey

•

Today

BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer. General Description: BeOne Medicines is seeking a highly motivated and organized Site Automation Engineer to join our team at the Hopewell, NJ site. The successful candidate will be responsib

Full-time

USD 114,700.00 - 154,700.00 per year

Spclst, Engineering

West Point, Pennsylvania

•

Today

Job Description West Point Technical Operations is seeking highly motivated individuals to provide engineering technical support for a vaccine packaging facility. The focus of the role involves providing technical leadership in the areas of project execution-including Change Requests (CRs)-and Artwork management. For project execution, tasks may include overseeing all the CRs within Packaging and leading project review meetings with CR owners, Quality approvers, and project stakeholders; ownin

Full-time

USD 87,300.00 - 137,400.00 per year

Search all similar jobs

More jobs at Katalyst Healthcares and Lifesciences in Morristown, NJ