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Senior Process Engineer

Dallas, Texas (On-Site)
5/13/2022

The Senior Process Engineer will work across the Engineering & Facilities organization to optimize process operations for the new startup sterile fill-finish facility located in Dallas, TX. The role will also be responsible for overseeing and managing the equipment & processes specific to weigh/ dispense, clean prep, formulation, sterile filling, isolators/RABS equipment, visual inspection, and labeling & packaging. In addition, the role will support the facility and clean utility equipment including but not limited to the following: ambient WFI generation/storage/distribution, compressed air generation/distribution, glycol chilling system, hot water system, HVAC, waste neutralization, cold room storage, and clean steam generation. Finally, the Senior Process Engineer will design, implement, and improve manufacturing processes in order minimize production cost without sacrificing quality.

DUTIES, RESPONSIBILITIES AND FUNCTIONS:

  • Plan, design and implement sterile fill-finish manufacturing processes
  • Collaborate and work alongside with the site general contractor (construction firm), MEP subs/contractors, and C&Q consultants in order manage and report out on project milestones, achieved or missed deliverables, and overall timelines.
  • Oversee the installation, start-up and commissioning of process, facility, and utility equipment for the new manufacturing site
  • Generate a critical spare parts and consumables list for cGMP equipment
  • Assist with redlining P+ID drawings, conduct walk downs & field inspection as needed
  • Support scale up activities from R+D to production
  • Source new equipment and estimations upon request
  • Support change controls and corrective action activities with the assistance of the Quality Unit
  • Analyze PLC controls and troubleshoot equipment alarms and breakdowns
  • Provide calibration support as needed
  • Develop and modify process formulations, methods and controls as needed
  • Assist with the development and review of manufacturing process documentation including but not limited to batch records, change controls, and other cGMP related documentation  
  • Ensure projects are carried out in compliance with established SOPs, GEPs, design standards and policies
  • Lead forecasting and resource requirement planning
  • Provide training on processes and systems to respective operations team members when necessary
  • Evaluate, manage, and report equipment and services capabilities
  • Lead continuous improvement projects supporting the commercial manufacturing site.
  • Support process improvement initiatives and work with cross functional teams to implement in improvements in manufacturing.
  • Work with the Quality Unit, Operations, and Supply Chain to provide technical expertise to regulatory filings and health authority questions.
  • Practical expertise with cGMP manufacturing and regulatory regulations and requirements for pharmaceuticals.
  • Support the implementation of automation, controls, and IT infrastructure projects as needed
  • Manage the writing and review of technical documentation (SOPs, protocols & summary reports for manufacturing, facility, and utility equipment and systems).
  • Provide technical input and support for the execution of C&Q activities as well as process validation
  • Monitor and analyze manufacturing data as necessary to provide support for process improvement, investigations, and continued process verification.
  • Participate and support process FMEAs to understand process and product risks as a pre-requisite for  process validation.
  • Participate and report to a cross-functional team to advance production activities.
  • Effectively & efficiently communicate manufacturing process performance internally and externally.
  • Support the implementation of automation, controls, instrumentation, and IT infrastructure projects.
  • Maintain a “Never willing to compromise on Quality” attitude.  

EDUCATION:

   •Bachelor’s Degree in Chemical, Mechanical, or Electrical Engineering with 10+ years of relevant work experience including 8+ years of experience in the Pharmaceutical or Biotech industry;  

    •Master’s Degree in Engineering preferred with 8+ years of relevant work experience including 6+ years of experience in the Pharmaceutical or biotech industry.

TRAINING & BASIC QUALIFICATIONS:

  • Extensive knowledge of cGMP, 21CFR 211, Part 11, GAMP, GDP requirements and other FDA regulations
  • Aseptic gowning experience and training required
  • Direct experience with regulated environments (i.e., cGMP, OSHA, EPA).
  • General understanding of Quality Systems
  • Working knowledge of pharmaceutical/biotech processes
  • Computer-savvy with SAP experience preferred
  • Project Management experience required; PM certification preferred
  • AutoCAD experience a plus
  • QMS experience and training preferred
  • Proficiency in Microsoft Office including Word, Excel, PowerPoint, Project, and Visio

WORK EXPERIENCE:

  • Minimum 8 to 12 years of experience working directly in the Pharmaceutical or Biotech industry  
  • At least 4 to 6 years of experience in a sterile manufacturing (Drug Product Ops) engineering role
  • Greenfield/Brownfield site or facility expansion construction and startup experience strongly preferred  
  • Experience interacting with FDA during inspection and audit
  • Facility startup and CQV experience strongly preferred  

PREFERRED QUALIFICATIONS:

  • Sterile fill finish manufacturing and/or Drug Product Ops experience (REQUIRED)
  • Demonstrated a working knowledge of pharmaceutical manufacturing equipment as well as facility and clean utilities equipment, aseptic processing, and process development & scale up
  • Automation, PLC controls & instrumentation experience
  • SCADA, PCS, BMS & EMS systems experience a plus
  • Ability to read/interpret engineering drawings (Electrical, Mechanical, etc.), design documents, P&IDs, PFDs, and System boundary drawings
  • In-depth understanding of scientific and engineering principles
  • Experience in statistical analysis
  • Knowledge of data management tools and statistical process controls
  • Process validation experience and supporting regulatory filings and inspections
  • Ability to think critically, and demonstrated troubleshooting and problem-solving skills
  • Excellent interpersonal, verbal, and written communication skills
  • Ability to function efficiently and independently in a fast-paced, changing environment
  • Self-motivated and willing to accept temporary responsibilities outside of the job description

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