Sr. Process Engineer

AstraZenecaFrederick, MD
$97,372 - $146,058Onsite

About The Position

As a Senior Process Engineer, you will be at the forefront of enhancing biopharmaceutical unit operations and automation. Your role is pivotal in selecting, designing, and implementing systems that drive efficiency and compliance. You will tackle technical challenges, optimize equipment, and lead change controls, all while supporting continuous improvement initiatives. Your expertise ensures adherence to regulatory standards and contributes to the overall success of our operations.

Requirements

  • Bachelor's in science
  • Extensive experience with biopharmaceutical unit operations, PLC, DCS, and advanced understanding of engineering principles.
  • Proven ability to solve complex technical issues.
  • Experience with root cause analysis and process improvements.
  • Experience leading teams or cross-functional projects.
  • Ability to manage multiple priorities and projects in a matrix environment.
  • Strong interpersonal skills to convey complex concepts and build productive relationships across departments.
  • Skilled in SAP, TrackWise, CAD, document management systems, and SharePoint.
  • 3-5+ years of industry experience.

Nice To Haves

  • Bachelor's in Engineering
  • Subject matter expertise in upstream or downstream production areas, such as incubators, bioreactors, centrifuges, chromatography columns, and freeze/thaw processes.
  • Master's degree

Responsibilities

  • Lead the selection and design of new or replacement systems.
  • Identify root causes of deviations and implement corrective actions.
  • Manage projects and initiatives, ensuring timely delivery within budget and quality goals.
  • Lead change controls related to equipment and systems.
  • Provide technical support during cGMP audits and train manufacturing staff on equipment operations.
  • Own critical documentation and maintenance procedures.
  • Lead or support FAT, SAT, commissioning, and validation activities.
  • Contribute to Lean initiatives and improve workplace safety and quality.
  • Work cross-functionally and interact with vendors, contractors, and diverse project teams.
  • Apply excellent communication skills to influence and negotiate effectively.

Benefits

  • Qualified retirement program [401(k) plan]
  • Paid vacation and holidays
  • Paid leaves
  • Health benefits including medical, prescription drug, dental, and vision coverage
  • Short-term incentive bonus opportunity
  • Eligibility to participate in our equity-based long-term incentive program (salaried roles)
  • Retirement contribution (hourly roles)
  • Commission payment eligibility (sales roles)
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