Senior Specialist II, Lead Investigator (Pharmaceutical Manufacturing)

Location: West Chester, Ohio, USA. Work is performed across office, laboratory, and cGMP manufacturing environments on an 8-hour Monday–Friday schedule.

Salary: $90,000–$123,750 per year, plus an annual cash bonus program.

Company

hirify.global is a technology-focused biomanufacturing company developing sustainable, end-to-end manufacturing solutions for medicines.

What you will do

• Lead complex, high-impact investigations by defining scope, strategy, timelines, resources, and status reporting.
• Author investigation reports covering issue definition, scope, product impact, root cause, and corrective actions.
• Coordinate cross-functional teams on communication, investigation tools, action plans, root cause decisions, and CAPA effectiveness checks.
• Prioritize concurrent investigations, escalate issues, and drive timely closure.
• Mentor and coach investigators on investigation methodology and report quality.
• Identify systemic and recurring issues and partner with functional leaders to improve investigation and deviation processes.

Requirements

• Experience in pharmaceutical manufacturing or another similar regulated industry.
• Familiarity with cGMP documentation practices and applicable regulatory requirements.
• Ability to assess technical data, conduct thorough investigations, and present complex findings clearly.
• Ability to manage multiple investigations against objectives and timelines while prioritizing customer needs.
• Strong written, verbal, presentation, and technical investigation report-writing skills.
• Work authorization or visa sponsorship support is not available for this position.

Nice to have

• Bachelor’s degree in science, engineering, regulatory studies, or a related discipline; relevant experience may substitute.
• 7+ years of experience in pharmaceutical or regulated manufacturing, including quality investigations and deviation management.
• Experience across multiple sites or functions and familiarity with internal core business processes.
• Knowledge of Lean problem-solving tools.

Culture & Benefits

• Work in a fast-paced, rapidly changing biomanufacturing environment.
• Healthcare coverage including medical, dental, and vision benefits.
• 401(k) plan with a company match, life and disability insurance, and family-building benefits.
• Paid vacation, paid holidays, and other paid leaves of absence.
• Tuition reimbursement and caregiving support.