Process Engineer

Job Title: Process Engineer (2 PM – 2 AM Shift).

Location: Dallas Area, TX (100% Onsite).

Start Date: ASAP – Soonest onboarding orientation start dates are 6/22 or 6/29.

Duration: 6–7 Months+ Contract.

Shift: 2 PM – 2 AM (12-hour rotating schedule).

Schedule: 2 Days On → 2 Days Off → 3 Days On → 2 Days Off (Every Other Weekend Required).

Position Overview:

• Our client is seeking an experienced Process Engineer to provide direct manufacturing floor support within an API pharmaceutical manufacturing environment.
• This role is highly operational and focused on real-time troubleshooting, process optimization, manufacturing support, investigations, and yield improvement initiatives.
• The ideal candidate will spend significant time on the manufacturing floor supporting day-to-day operations, resolving process and equipment issues, driving process improvements, and supporting validation and automation-related activities.
• This is not a design-focused role; instead, it requires a hands-on engineer capable of owning manufacturing processes and responding to production challenges in real time.

Key Responsibilities - Manufacturing Floor Support:

• Provide hands-on engineering support within pharmaceutical manufacturing operations.
• Troubleshoot process and equipment issues in real time during active manufacturing.
• Support day-to-day plant operations and manufacturing activities.
• Work directly with operators, maintenance, quality, and production teams.

Process Optimization & Continuous Improvement:

• Drive yield improvement initiatives.
• Optimize manufacturing cycle times.
• Support process performance improvements and operational excellence initiatives.
• Identify opportunities to improve production efficiency and product quality.

Investigations & Technical Support:

• Lead and support manufacturing investigations.
• Perform root cause analysis (RCA) for process deviations and manufacturing issues.
• Develop impact assessments addressing quality, safety, and production risks.
• Analyze manufacturing trends and production data.

Continued Process Verification:

• Support Continued Process Verification (CPV) activities.
• Monitor process performance and identify areas for improvement.
• Evaluate manufacturing data to ensure process consistency and reliability.

Automation & SCADA Support:

• Support execution of functional testing activities.
• Assist with IQ/OQ activities related to Rockwell FactoryTalk Automation 2.0.
• Support Human Machine Interface (HMI) validation and troubleshooting.
• Work with FactoryTalk Rockwell Automation Platform.
• Support AVEVA/Wonderware SCADA systems.

Validation Support - Execute or support:

• IQ (Installation Qualification).
• OQ (Operational Qualification).
• PQ (Performance Qualification).
• PPQ (Process Performance Qualification).

Manufacturing Systems Support - Work with manufacturing systems across:

• IT Systems.
• MES Platforms.
• Process Control Systems (PCS).
• Safety Systems.
• Quality Systems.

Required Qualifications (Manufacturing Experience):

• Strong pharmaceutical manufacturing experience.
• Experience supporting batch manufacturing operations.
• Hands-on process engineering experience within active manufacturing environments.
• Manufacturing shift support/process support engineering experience.
• Experience troubleshooting manufacturing processes directly on the production floor.

Process Engineering Experience:

Direct ownership of:

• Process optimization.
• Yield improvements.
• Cycle time reduction.
• Manufacturing investigations.
• Operational support.

Automation & SCADA:

Experience with:

• FactoryTalk Rockwell Automation Platform.
• AVEVA/Wonderware SCADA.

Data Historian Experience:

Familiarity with:

• OSIsoft PI Data Historian
• PI ProcessBook

Technical Skills:

• Strong troubleshooting skills.
• Root Cause Analysis (RCA).
• Data analysis and trend evaluation.
• Technical writing and risk assessment development.
• Ability to confidently lead technical discussions.

Work Style:

• Self-starter.
• Quick learner.
• Independent thinker.
• Comfortable working with minimal supervision.
• Able to perform in a fast-paced manufacturing environment.

Location & Shift Requirements - Onsite Requirement:

• 100% onsite in Coppell, Texas (Dallas/Fort Worth Area).
• No remote work available.

Candidate Location Preference:

• Texas-based candidates strongly preferred.
• Non-local candidates will be considered if willing to relocate for the contract duration.

Shift Requirement:

• 2 PM – 2 AM shift support.
• Ability to work rotating 12-hour shifts.
• Every other weekend required.
• Flexibility to occasionally support alternate shifts when business needs arise.

Preferred Qualifications & Qualification & Validation:

Experience supporting:

• IQ.
• OQ.
• PQ.
• PPQ.

Unit Operations Experience:

• Batch Reactors
• Agitation Systems
• Filter Dryers
• Filtration Systems
• Acid/Base Reactions
• API Handling
• Solids Processing
• Bulk Packing Equipment
• Vacuum Transfer Systems
• Vacuum Pumps
• Heat Exchangers
• Condensers
• Pulse-Jet Filters

MES Experience:

• PAS|X Electronic Batch Records

Additional Pharmaceutical Experience:

• API Manufacturing.
• Batch Pharmaceutical Manufacturing.
• Manufacturing Process Ownership.
• Process Verification.
• Production Support Engineering.