Process Engineer

Process Engineer

Position Summary

This position will provide engineering designs and recommendations for assigned processes and new technologies to develop the most cost-effective solutions for manufacturing.

Job Duties

• Prepare, review, approve and distribute the instructions for the production of intermediates or APIs according to written procedures.
• Produce APIs and intermediates according to preapproved instructions.
• Review all production batch records and ensure that these are completed and signed.
• Report and evaluate all production deviations and ensure that all critical deviations are investigated, with conclusions recorded.
• Ensure that production facilities are clean and disinfected.
• Ensure that all necessary calibrations are performed and documented.
• Maintain the premises and equipment, with records kept.
• Ensure that validation protocols and reports are reviewed and approved.
• Evaluate proposed changes in product, process, or equipment.
• Ensure that new and modified facilities and equipment are qualified.
• Review and analyze manufacturing needs, formulate solutions, and implement changes to optimize manufacturing processes.
• Manage assigned projects to ensure completion on time, within budget, and in accordance with design parameters.
• Provide training for API processes.
• Perform other duties as assigned.

Required Qualifications

• Education: Bachelor's degree in Chemical Engineering, or related engineering discipline.
• Regulated Manufacturing Experience: Minimum of 5 years of experience working in a regulated manufacturing environment.
• Organizational Skills: Demonstrated ability to effectively manage multiple priorities, projects, and deadlines in a fast-paced environment.
• Communication & Presentation Skills: Ability to effectively communicate technical concepts and present ideas to all levels of the organization, including leadership.
• Business Knowledge: Working knowledge of business operations, budgeting processes, production planning, and key business performance metrics.
• Manufacturing Environment: Demonstrated ability to operate effectively and make sound decisions in a fast-paced manufacturing environment.
• Cross-Functional Collaboration: Proven ability to partner effectively with Quality, Operations, Technical Services, and other cross-functional teams to achieve business objectives.
• Business Acumen: Demonstrates an understanding of the broader business environment and how engineering decisions support operational and organizational success.

Preferred Qualifications

• Solids handling process development and scale-up: Developing and optimizing centrifugation (isolation), drying, milling, and powder-handling processes from pilot scale through commercial manufacturing.

• Material attribute control: Designing equipment, operating conditions, and control strategies to achieve target particle size, moisture content, residual solvent levels, purity, bulk density, tapped density, and flowability.

• Technical Leadership: Demonstrated ability to lead projects, influence cross-functional teams, drive process improvements, and provide technical guidance within a manufacturing environment.

• FDA/GMP Experience: Minimum of 5 years of experience operating within FDA-regulated and GMP manufacturing environments.
• DEA Compliance Knowledge: Experience working within DEA guidelines and regulatory requirements.
• Quality Systems Experience: Experience working within FDA-regulated quality systems, including change control processes.
• Process Automation: Experience with Distributed Control Systems (DCS) and process automation platforms.

The presently-anticipated base compensation pay range for this position is $103,000 to $114,500. Actual base compensation may vary based on a number of factors, including but not limited to geographical location and experience. In addition, this position is part of the Annual Performance Bonus Plan. Employees are eligible to participate in Company employee benefit programs which include medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; and the employee assistance program. Employees also receive various paid time off benefits, including vacation time and sick time.

The compensation and benefits described above are subject to the terms and conditions of any governing plans, policies, practices, agreements, or other materials or documents as in effect from time to time, including but not limited to terms and conditions regarding eligibility. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company, or individual department/team performance, and market factors.