Technical Operations Engineer (On-site)

Job Description

Role Overview:

The 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.
• Identify opportunities to expand equipment operating ranges change-part capability manufacturing flexibility and asset utilization.

Collaboration & Team Development:

• Communicate technical information clearly to operators engineers scientists mechanics automation personnel quality representatives and leadership.
• Coach and train colleagues on assigned equipment standard work troubleshooting approaches and compliant execution.
• Contribute to team standard work technical reviews knowledge sharing and continuous improvement priorities.

Education Minimum Requirements:

• B.S. or M.S. degree in Chemical Engineering Biomedical Engineering Pharmaceutical Sciences or related discipline with a minimum of 3 years relevant industrial experience.

Required Qualifications:

• Experience supporting technical work manufacturing operations equipment or process improvement in a laboratory pilot plant pharmaceutical biotechnology or other regulated environment.
• Demonstrated ability to troubleshoot technical problems organize actions and drive issues toward resolution.
• Ability to author and review clear technical documentation and work in accordance with controlled procedures.
• Strong planning prioritization communication and cross-functional collaboration skills.
• Ability to work effectively in an on-site manufacturing environment and support changing operational priorities.
• Ability to meet applicable medical screening and physical requirements for the manufacturing area.

Preferred Qualifications:

• Experience in GMP pharmaceutical or biotechnology manufacturing and knowledge of Good Documentation Practices.
• Experience with oral solid dosage or specialty processes such as tablet compression encapsulation spray drying film coating blending granulation powder handling containment or device assembly.
• Experience with equipment ownership maintenance coordination automation troubleshooting investigations CAPAs change controls or risk assessments.
• Experience supporting capital projects commissioning qualification validation FAT/SAT or equipment startup.
• Experience with Lean Six Sigma structured problem solving or continuous improvement methods.
• Experience with digital manufacturing systems and tools such as PAS-X SAP PI/historian systems Power BI data analytics platforms or maintenance/calibration systems.
• Experience using data to evaluate equipment performance downtime capacity or recurring operational issues.

EligibleforERP

Required Skills:

Preferred Skills:

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The primary location for this posting is:

Where required by law the compensation range for this role is provided below.

The salary range for the primary location of this role is:

This range reflects the Companys reasonable expectation of the base salary applicable to this role at the time of posting. An employees position within the salary range will be based on several factors including but not limited to relevant education qualifications certifications experience skills geographic location government requirements and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive if applicable.

We offer a comprehensive package of benefits. Available benefits include medical dental vision healthcare and other insurance benefits (for employee and family) retirement benefits including 401(k) paid holidays vacation and compassionate and sick days. More information about benefits is available at location(s): Please note the salary range above applies to the Primary Location of the position. Where a role has other listed locations different compensation guidelines may apply. You may find the salary ranges for additional locations below. If the salary range is not listed for the location you are applying to our Talent Acquisition team will provide further information to you relevant to your location.

Additional location(s) Compensation Information:

San Francisco Residents Only:We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only:We will consider for employment all qualified applicants including those with criminal histories in a manner consistent with the requirements of applicable state and local laws including the City of Los Angeles Fair Chance Initiative for Hiring Ordinance

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