Associate Specialist, Technical Operations Engineer (On-site)

Job Description

Role Overview:

The Assoc. Specialist, Engineering serves as a Tech Ops Engineer supporting FLEx Non-Sterile clinical manufacturing operations. This role is responsible for equipment ownership, production readiness, on-floor technical support, troubleshooting, investigation support, engineering change execution, and continuous improvement to enable safe, reliable, and compliant delivery of clinical supplies.

The engineer partners closely with Production, Process Engineering, Quality, Facilities, Maintenance, Automation, capital project teams, and other program stakeholders. The position combines hands-on manufacturing support with technical problem solving, documentation, data use, and sustained improvement of equipment and operational systems.

Primary Responsibilities:

Equipment Ownership & Technical Readiness:

• Own one or more manufacturing equipment trains or technical capability areas within FLEx Non-Sterile operations.
• Maintain equipment readiness through preventive action tracking, alarm and performance review, procedural updates, training support, and coordination of required maintenance or engineering work.
• Serve as a technical point of contact for equipment operation, setup, changeover, cleaning, assembly, disassembly, and troubleshooting.
• Coordinate with Process Engineering, Maintenance, Automation, Facilities, vendors, and other subject matter experts to resolve equipment and system issues.
• Support equipment changes, automation or mechanical improvements, and change control activities in accordance with applicable procedures.
• Develop and maintain equipment knowledge, technical references, standard work, and lessons learned; share knowledge through coaching and training.

Production Readiness & Operational Support:

• Support campaign readiness by coordinating equipment, room, utility, documentation, training, material, and technical support needs.
• Provide on-floor engineering support during manufacturing campaigns, turnovers, changeovers, and other critical operations.
• Respond to escalations, clarify ownership, stabilize immediate concerns, and coordinate an effective path to resolution.
• Partner with Production and Process Engineering to identify schedule constraints, assess technical risks, and support recovery plans.
• Support batch execution and closeout activities as needed to ensure safe, compliant, and reliable production.
• Participate in shift handoffs and cross-shift support to maintain continuity of technical information and actions.

Investigations, Problem Solving & Compliance:

• Lead or support troubleshooting, deviation and atypical-event investigations, root cause analysis, and corrective and preventive actions for equipment, automation, and operational issues.
• Apply structured problem-solving methods to identify root causes, establish sustainable actions, and verify effectiveness.
• Author, revise, and review GMP documentation, including SOPs, batch or equipment instructions, risk assessments, change controls, investigation records, and technical assessments.
• Ensure work is performed in compliance with GMP, Good Documentation Practices, safety, environmental, and company requirements.
• Support audit readiness, internal and external inspections, walkthroughs, and timely closure of identified actions.
• Promote a learning-focused escalation culture that encourages early identification of risk and collaborative resolution of problems.

Continuous Improvement & Digital Manufacturing:

• Lead focused improvement initiatives for assigned equipment or processes to improve safety, quality, reliability, capacity, turnaround time, and ease of execution.
• Use operational data, batch reports, alarm history, downtime information, and action trackers to identify recurring issues and improvement opportunities.
• Support digital manufacturing systems and workflows, including electronic batch records and logs, dashboards, scheduling tools, historian data, and escalation tracking.
• Define and improve standard work, production flow, issue tracking, knowledge management, and visual management practices.
• Partner with operations and technical stakeholders to test, implement, and sustain new tools, equipment upgrades, and automation solutions.
• Track actions to completion and communicate status, risks, decisions, and results to affected stakeholders.

Capital Projects & Capability Expansion:

• Provide operations and equipment subject matter expertise for capital projects, equipment upgrades, and capability expansion initiatives.
• Participate in design reviews, risk assessments, vendor engagement, FAT/SAT activities, commissioning, qualification, startup, and operational handover, as assigned.
• Represent operational requirements for equipment usability, cleaning, maintenance, training, documentation, digital integration, and long-term support.
• Coordinate project work with the manufacturing schedule and support safe, controlled return of equipment or areas to service.

…