Use Your Power for Purpose
Whether you are involved in the design and development of manufacturing processes for clinical products or supporting maintenance and reliability, engineering is critical to ensuring that customers and patients receive the medicines they need when they need them.
We are seeking a highly motivated individual for the role of Validation Engineer III within Drug Product Manufacturing & Supply (DPMS) in Groton, CT. Our GMP facilities utilize advanced manufacturing technologies to produce solid oral dosage forms for Phase I – III clinical studies. The Validation Engineer III supports the Validation Technical Support (VTS) team to enable compliant project delivery and maximizing equipment uptime.
Manufacturing technologies supported include both continuous and batch processing equipment. Responsibilities include implementation of new production equipment (installation and lifecycle management), change management, equipment troubleshooting, and "right to operate" responsibilities for a GMP area (investigation writing and support, periodic reviews, data integrity assessments, etc.).
As a Validation Engineer III, you will work closely with the Operations team, compliance team, process intelligence / automation team, and others internal to the business line to ensure timely and robust manufacturing solutions. You will liaise regularly to partner lines and external vendors. This is an individual contributor role but may review the work of other colleagues and serve as a mentor.
What You Will Achieve
In this role, you will:
Scope equipment based on project need and facility/installation constraints.
Oversee Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT) alongside vendors. Oversee issue resolution.
Perform lifecycle management of direct impact manufacturing equipment. Perform equipment validation and qualification (IQ/OQ/PQ)
Establish preventative maintenance and calibration programs for novel equipment.
Own equipment reliability and availability. Address technical problems during upset conditions.
Maintain the compliant state of the equipment within a cGMP facility.
Other duties include, but are not limited to:
Immediate response and support to manufacturing operations.
Propose and lead continuous improvement projects.
Performing environmental health and safety (EHS) assessments. Play an active role in industrial hygiene protocols and cleaning protocols.
Work in and perform changes within digital systems.
Perform processing equipment tag validation.
Drive timely resolution of quality deviations and lead root cause analysis or CAPAs for manufacturing investigations.
Here Is What You Need (Minimum Requirements)
BA/BS with at least 4 years of experience or MBA/MS with at least 2 years of experience or PhD/JD with any years of experience or associate's degree with at least 8 years of experience or high School Diploma (or Equivalent) with at least 10 years of relevant experience.
Knowledge and background in equipment lifecycle management.
Strong knowledge of industry practices in a cGMP controlled environment.
Background in lean manufacturing and 6 Sigma or equivalent tools.
Excellent communication and organizational skills
Experience with data visualization tools (e.g., Spotfire)
Bonus Points If You Have (Preferred Requirements)
Master’s degree with relevant experience
Practical experience in facilitating and conducting risk assessments.
Experience using AI tools.
Experience implementing changes/upgrades and troubleshooting of computerizedoperating systems through an understanding of network infrastructure and automation solutions. Including:
HMIs (Human Machine Interfaces)
PLCs (Programable Logic Controllers)
IDCs (Industrial Data Centers)
VMs (Virtual Machines)
WINCC
PHYSICAL/MENTAL REQUIREMENTS
The job requires to operate pieces of manufacturing equipment in the Groton drug product manufacturing facilities. Requires occasional travel (ie, equipment vendor sites) which may be…