# Manufacturing Technical Operations

> BioPharma Consulting JAD Group · Boston, United States · Contract · Posted 2026-09-11

**Workplace:** on_site

## Description

The Manufacturing Technical Operations (MTO) team, responsible for independently executing high‑complexity quality records that support cell therapy manufacturing at the Boston site. This role is **investigation‑heavy**, focusing on Deviations, CAPAs, Change Controls, and Analytical/Quality Control investigations within the electronic Quality Management System (eQMS). The Senior Specialist leads triage, SME coordination, root cause analysis, and drives timely, compliant closure of records in a fast‑paced, highly regulated environment.

**Key Responsibilities**

-   Lead **full‑complexity deviation investigations**, including triage, data collection, GEMBA walks, and coordination with cross‑functional SMEs.
-   Perform advanced **root cause analysis** using structured methodologies (5‑Why, Fishbone, GEMBA, KT).
-   Independently own **CAPA records** from initiation through closure, ensuring robust effectiveness checks and alignment with compliance expectations.
-   Initiate, assess, and execute **Change Control** records, ensuring accurate impact evaluations and cross‑functional alignment.
-   Conduct and support **Analytical and QC investigations**, including data trending, method performance review, and identification of systemic issues.
-   Ensure all quality records meet internal, regulatory, and industry standards for completeness, accuracy, and timeliness.
-   Partner closely with Manufacturing, QC, QA, MS&T, Engineering, and Supply Chain to drive investigation closure and continuous improvement.
-   Provide subject matter expertise during internal audits, external inspections, and regulatory interactions.
-   Identify recurring issues and lead cross‑functional initiatives to strengthen process robustness and reduce deviation frequency.
-   Serve as a mentor and technical resource for junior investigators and MTO staff.

## Requirements

-   Bachelor’s degree in **Engineering**, **Life Sciences**, **Biotechnology**, **Project Management**, or related field.

-   **5–10 years** of experience in pharmaceutical, biotechnology, cell therapy, or regulated manufacturing environment.
-   Demonstrated ability to independently lead **complex investigations** and CAPA execution.
-   Strong understanding of **cGMP**, FDA/EMA regulations, and quality systems.
-   Experience with electronic Quality Management Systems (eQMS) required.
-   Exceptional analytical, problem‑solving, and technical writing skills.
-   Ability to operate autonomously in a fast‑paced, dynamic manufacturing environment.
-   Proven ability to influence cross‑functional teams and drive timely record closure.

**Preferred Skills**

-   Experience in cell therapy, biologics, aseptic processing, or advanced therapy manufacturing.
-   Proficiency with MES, LIMS, TrackWise, or similar systems.
-   Formal training in RCA methodologies (Kepner‑Tregoe, Ishikawa, 5‑Why).
-   Experience mentoring or training junior investigators.

## Benefits

-   1- year contract with possible extension
-   Administrative shift  
    Overtime Availability

## Apply

[Apply at BioPharma Consulting JAD Group](https://apply.workable.com/biopharma-consulting-jad-group/j/031E05E259/apply)

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