Senior Process Engineer

Job Title: Senior Process Engineer

Job Location: Morristown, NJ

Job Type: Contract

Job Overview:

Pay Range: $60.95hr - $65.95hr

Requirement/Must Have:

• Thorough knowledge of cGMPs and regulatory requirements related to development, engineering, and validation of pharmaceutical products.
• Comprehensive knowledge of drug product manufacturing for solid and liquid oral dosage forms.
• Ability to work in cross-functional teams with strong analytical, troubleshooting, and root cause analysis skills.
• Knowledge of product manufacturing, formulation, quality, FDA and EMA regulations, technical transfer, process development, and validation.
• Skilled in improving productivity, cost analysis, and plant equipment evaluation.
• Strong technical writing skills and ability to manage multiple projects effectively.
• Project management skills and proficiency with Microsoft Office tools.
• Excellent verbal and written English communication skills for technical discussions, emails, and presentations across all organizational levels and with suppliers and customers.
• Experience in third-party manufacturing, technical services support functions, and plant operations.
• Good knowledge and hands-on experience with Word, Excel, and PowerPoint.

Experience.

• 8 to 10+ years of experience in Pharmaceutical Operations or Technical Operations with the application of cGMPs in the pharmaceutical or related regulated industry.
• 10+ years of experience in a Technical Services or Engineering function.

Responsibilities:

• Provide technical support for all products manufactured externally at third-party contract manufacturers across North American locations.
• Travel frequently to third-party manufacturing sites for batch monitoring.
• Act as the technical expert on product formulations, scale-up activities, process validation, equipment qualification, process-related technical issues, and investigations.
• Ensure manufacturing sites adhere to GMP and regulatory guidelines.
• Review and/or author technical protocols, reports, and memos.
• Lead Continued Process Verification (CPV) activities across Contract Manufacturing Organizations (CMOs).
• Oversee data collection and analysis to ensure ongoing process performance and control.
• Partner with CMOs to identify and mitigate risks and drive continuous improvements to strengthen product robustness.
• 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 for new and existing products.
• Support multifunctional teams in developing plans and strategies 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.

Should Have:

• Knowledge of API manufacturing.

Skills:

• Pharmaceutical process engineering.
• Technical services.
• cGMP compliance.
• Process validation.
• Equipment qualification.
• Continued Process Verification (CPV).
• Technical transfer.
• Root cause analysis.
• Regulatory compliance (FDA and EMA).
• Technical writing.
• Project management.
• Microsoft Office Suite.

Qualification and Education:

• Bachelor of Science in Pharmacy, Engineering, Chemistry, or a related field.