B87 Filling and Form Manager 3rd Shift (Aseptic Manufacturing)

Location: Swiftwater, Pennsylvania, United States. Third-shift leadership role with flexible scheduling during startup and qualification; extended shifts and weekends may be required.

Salary: $90,000–$130,000 per year.

Company

hirify.global is an R&D-driven biopharmaceutical company developing medicines and vaccines, with manufacturing operations focused on aseptic processing and digital innovation.

What you will do

• Lead aseptic filling and formulation operations through facility startup, commissioning, qualification, and commercial readiness.
• Drive media fills, environmental monitoring performance qualifications, smoke studies, cleanroom qualification, and PPQ execution.
• Ensure GMP compliance, regulatory readiness, inspection preparation, and timely closure of quality items and deviations.
• Own shift performance using operational standards, digital tools, data analytics, and real-time problem solving.
• Build, train, coach, and develop a high-performing operations team from startup through commercial launch.
• Serve as the aseptic operations subject matter expert across Commissioning & Qualification and validation activities.

Requirements

• Bachelor’s degree in life sciences, engineering, or a related field plus 1+ year of pharmaceutical/GMP manufacturing experience and 6+ months of people leadership; or a high school diploma plus 5+ years of pharmaceutical/GMP manufacturing experience and 1+ year of people leadership.
• Demonstrated experience in aseptic processing operations, including drug substance, drug product, or biologics.
• Strong knowledge of GMPs and regulatory compliance requirements.
• Proven ability to build, develop, and manage teams, with strong technical writing, communication, and interpersonal skills.
• Ability to work flexible hours, including third shift, extended shifts, weekends, and shift-aligned qualification activities.
• Proficiency with digital systems and data analytics tools.

Nice to have

• Experience with facility or production-line startup, commissioning, qualification, media fills, APS, or PPQ.
• Experience in biologics, vaccines, or sterile drug product manufacturing.
• Knowledge of Lean, Six Sigma, SMS 2.0, Industry 4.0, or digital manufacturing tools.
• Experience hiring and developing new teams or managing change in regulated manufacturing.

Culture & Benefits

• Opportunity to build operations from the ground up in a state-of-the-art aseptic facility.
• Exposure to advanced aseptic processing technology and next-generation manufacturing practices.
• Career development and growth opportunities within an expanding organization.
• Healthcare, wellness programs, and at least 14 weeks of gender-neutral parental leave.
• Collaborative environment focused on curiosity, digital thinking, continuous improvement, and challenging the status quo.