Process Engineer II

Title: Process Engineer II
Duration: 24 months+ Possible Extension
Location: Morristown, NJ- Hybrid
Pay Range: $58/hr- $63/hr

Manager Notes:

• M-F, Hybrid 3 days onsite (one of the three needs to be a Monday or Friday).
• 8-10 years pharma or technical experience.
• Bachelor’s degree minimum.

MUST HAVE:

• Small Molecule experience. Not interested in candidates with Biologics/Large Molecule.

Day in the life:

• Main responsibility is to support the contract manufacturing orgs (CMOs), some special projects relevant to specific products.
• They would get info and work with CMOs and external manufacturing groups in NA, evaluate their current situations and request technical documents, complete a technical review, provide their SME opinion, review the documents.
• If an activity requires someone to be onsite, the person would need to travel to that site to gather data.
• They'll create spreadsheets to evaluate data trends and will provide feedback based on trends.
• They'll utilize their expertise in process validation, troubleshooting, equipment issues, investigations, and review protocols.

Description:
The role of this technical position serves as an inhouse pharmaceutical process expert to support MSAT (Manufacturing, Sciences, Analytics & Technology) Synthetics with technical plans for new products, product line extensions and manufacturing site technical transfers of Client commercial products.

Key Objectives:
Oversee technical services activities and engineering at third party manufacturing sites (CMOs) and ensure compliance with Good Manufacturing Practices. Interact with MSAT, External Manufacturing, Regulatory and Quality teams in addition to third party manufacturing sites, and Client sites outside the US which manufacture small molecule oral dosage forms for global markets. Work with and manage third party technical activities ensuring adherence to cGMPs and Regulatory guidelines.

Key Duties and 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.
• 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.

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.
• 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.
• Soft skills: 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.

Basic 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.