Process Engineer

Process Engineer, Formulation

We are seeking a Process Engineer, Formulation to support pharmaceutical product development and commercialization efforts. This role will be responsible for leading process design, scale-up, and validation activities across multiple product lines while serving as a technical leader within the organization. This is a critical backfill due to a Principal-level departure and requires someone who can step in quickly and drive impact.

Responsibilities

Lead process development, scale-up, and validation of pharmaceutical formulations from lab to commercial scale.

Drive process design, optimization, and control strategy using Design for Manufacturing (DfM) principles.

Identify and optimize critical process parameters to ensure product quality and robustness.

Develop and manage Bills of Materials (BOMs), batch records, and formulation recipes including order of addition and process flow.

Lead execution of process validation, equipment qualification (IQ/OQ/PQ), and scale-up activities.

Support regulatory submissions including NDA/ANDA filings with process sections.

Conduct risk assessments, DOE studies, and statistical analysis to support scalability and performance improvements.

Manage 12–20 concurrent projects across multiple business lanes such as R&D, business development, contract manufacturing, alternate API, and product reactivation.

Create technical documentation including protocols, reports, and analytical test plans.

Lead cross-functional collaboration with R&D, Quality, Operations, and external partners.

Drive continuous improvement initiatives, troubleshooting, and root cause investigations (CAPA).

Serve as a technical leader and mentor to junior engineers.

Essential Skills

Bachelor's degree in Chemical Engineering, Pharmaceutical Sciences, or related field.

8–10+ years of experience in process engineering within pharmaceuticals, specifically drug product.

Strong experience in formulation development and process engineering.

Expertise in solid dose and/or liquid formulations, process scale-up, and technology transfer.

Experience with process and formulation validation.

Familiarity with FDA regulations, cGMP, and regulatory filings.

Exposure to multiple dosage forms.

Experience with quality investigations and deviation management.

Familiarity with DOE, PAT, and statistical modeling tools.

Additional Skills & Qualifications

Strong leadership and ability to influence across teams.

Demonstrated ability to manage competing priorities and deadlines.

High level of ownership and accountability.

Problem solver with strong technical depth.

Ability to operate as both a strategic thinker and hands-on executor.

Work Environment

The role operates within a clean, regulated environment. It requires adherence to cGMP standards and collaboration within a great company culture and collaborative environment.

Job Type & Location

This is a Contract to Hire position based out of Columbus, OH.

Pay and Benefits

The pay range for this position is $43.27 - $57.69/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully onsite position in Columbus, OH.

Application Deadline

This position is anticipated to close on Jul 9, 2026.