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.

Pyramid Consulting, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or a