Validation Engineer Xcellerex

Summary
Xcellerex is a manufacturer of single-use bioreactors, mixers and integrated FlexFactory biomanufacturing
suites. The validation engineer will be responsible for the development and execution of qualification protocols
for this biopharmaceutical manufacturing equipment and utilities, and will help coordinate validation activities at
client sites among other Xcellerex departments and/or contract resources.
Essential Functions
? Responsible for developing and executing protocols for individual equipment and/or coordinating
qualification of FlexFactory biomanufacturing suites (including unit operations) at Xcellerex and onsite at
customer facilities post-delivery.
? Coordinate and assemble a complete validation package prior to execution and perform and/or
coordinate the qualification of Xcellerex equipment and FlexFactories at customer facilities.
? Assist with commissioning (FAT/SAT), calibration or other related functions as needed.
Knowledge, Skills and Abilities
? Must have a working knowledge of cGMP regulations and ICH guidances regarding validation policy
? Must have sufficient experience with manufacturing equipment and utilities to understand how to
develop and execute qualification protocols accurately.
? Must be able to work independently and effectively to assure that qualifications are completed on time
and with efficient use of resources.
? Must be able to work well in a matrix organization, borrowing and directing resources to drive the
completion of validation work.
? Must have excellent communication skills and the ability to build and establish a good rapport with
customers.
Working conditions
The person in this position is expected to work independently while also working effectively in a matrix
management role. He or she must have the ability to determine the best course of action in situations where
procedures and precedents are not established.
Minimum qualifications
? BS with advanced degree preferred.
? Minimum of 3-5 years in a biomanuacturing operation in a manufacturing, engineering or quality role
with at least 2 years of hands on validation experience.
? Line management experience.
? Experience generating validation policy.
? Experience in a contract service organization desired.
? Must have the ability to travel globally at client sites for validation activities.
? Prior experience or working knowledge with DCS/SCADA, GAMP and/or Computer System Validation.
? Prior experience in a biopharmaceutical equipment company..
Success factors
The ideal candidate will be self-motivated, largely self-sufficient and capable of handling a significant workload
through efficiency and prioritization. They will be effective at coordinating work in a group environment to see
tasks through to their successful conclusion. The ideal candidate will have solid hands-on skills with the
qualification of equipment and utilities.

Location:	170 Locke Drive Marlborough, MA 01752 United States