Process Engineer II (Engineering) - Small Molecule

Immediate need for a talented Process Engineer II (Engineering) - Small Molecule. This is a 12-24 months contract opportunity with long-term potential and is located in Morristown, NJ(Hybrid). Please review the job description below and contact me ASAP if you are interested.

Job ID:26-10581

Pay Range: $50 - $59/hour.  Employee benefits include, but are not limited to, health insurance (medical, dental, vision), 401(k) plan, and paid sick leave (depending on work location).

Key Responsibilities:

• Note -Hybrid 3 days onsite (one of the three needs to be a Monday or Friday).
• Notes from Manager: 
• 8:30-4:30 with some flex if they want to start a little earlier.
• 2-year assignment.
• 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.
• Act 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.

Key Requirements and Technology Experience:

• Must have skills:  8-10 years of pharma or technical experience
• Small Molecule
• Work with CMOs and external manufacturing groups in NA, evaluate their current situations, request technical documents, complete a technical review, provide their SME opinion, and review the documents
• Expertise in process validation, troubleshooting, equipment issues, investigations, and review protocols.
• Bachelor's degree minimum.
• 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.
• Ability 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.
• Strong technical writing skills, ability to manage multiple projects effectively, project management skills, and proficiency with MS Office tools.
• Excellent English skills - verbal and written. For example, responsibilities include internal and external interactions, technical discussions, e-mail, presentations, etc. at all levels of associates within the client organization and with suppliers and customers.
• 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.

Our client is a leading Pharmaceutical Industry, and we are currently interviewing to fill this and other similar contract positions. If you are interested in this position, please apply online for immediate consideration.

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