Manufacturing Technical Operations Specialist

Job Description

Title: Senior Manufacturing Technical Operations Specialist

Location: Greater Boston / Seaport Area, MA (Onsite)

Employment Type: Contract (12 months + possible extension or conversion)

Status: Accepting Candidates (Multiple Openings)

About the Role:

We are hiring Senior Manufacturing Technical Operations professionals to support real-time manufacturing operations at a large, commercial biopharmaceutical facility. This is a highly hands-on, floor-based role focused on issue triage, investigations, and cross-functional collaboration in a fast-paced GMP manufacturing environment.

Key Responsibilities:

• Triage manufacturing issues in real time on the manufacturing floor
• Lead and author investigations for quality events across cell manufacturing, QC, material operations, and facilities
• Apply structured root cause analysis tools to identify issues and drive resolution
• Collaborate with subject matter experts to determine immediate actions, containment strategies, and impact assessments
• Partner with cross-functional teams to identify root cause and propose corrective and preventive actions (CAPAs)
• Support strong quality documentation practices in a GMP-regulated environment

Qualifications:

• 6+ years of progressive experience in pharmaceutical development or manufacturing
• 4+ years of hands-on analytical investigations and Quality Control experience
• Strong background in analytical investigations and quality documentation
• Experience supporting QC / analytical operations in GMP manufacturing
• Exposure to facility or calibration investigations is a plus (not required)
• Strong scientific mindset with the ability to interpret data, apply root cause analysis, and think systematically

Compensation (MA Pay Transparency):

• Estimated hourly range: $50–$58/hr (W-2)
• Final rate within this range will be based on experience, skill set, shift alignment, and interview results