Commissioning, Qualification & Validation Engineer/Specialist

Compliance Technology Group, Inc., is currently seeking a Commissioning/Validation Specialist/Engineer to work at one of CTG’s top clients on a variety of equipment qualification projects. Qualified candidates will participate in laboratory benchtop equipment qualification, thermal mapping, smoke studies, EMPQs, and other validation activities at our client’s biotechnology facility. The Commissioning/Validation Specialist/Engineer will be able to develop and/or execute the following documents for various manufacturing equipment:

Annex 11 Assessment
Part 11 Assessment
URS (User Requirement Specification)
FS (Functional Specification)
DS or DDS (Detailed Design Specification)
IV (Installation Verification)
OV (Operational Verification)
PQ (Performance Qualification)
PV (Process Verification)
EMPQ
Thermal Mapping Study

Requirements and Duties:
Other responsibilities include maintaining direct communication with the on-site Project Leader and client to ensure the commissioning/qualification and validation testing is properly implemented, executed, and completed in compliance with corporate and federal policies and procedures.
Work Experience:
Kneat Digital Validation experience preferred
Experience with BSC and LFG Certification and Qualification
Smoke Study Experience a plus
CIP Sampling (rinse/swabs)
SIP Temp Mapping
Autoclave Qualification Experience
CTUs Qualification Experience
AVS/KAYE/Valprobes Knowledge
Write/Revise SOPs, WI, FRMS, IOPQ, and Validation Maintenance reports
Perform Automation Data Review
Able to work in a fast-paced environment
Former JNJ Experience is a plus
Other:
3+ years of experience in the biopharm industry.
A thorough understanding of the GMP regulatory environment, validation, and associated subjects.
An ability to work independently and take ownership of work from start to finish.
Excellent verbal and written communication skills.
Proficiency in Windows and Microsoft Office applications.
Knowledge of cleaning I methods I process validation, a plus.
Proficient in the use of Kaye AVS for thermal mapping studies.
Solid understanding of Kneat validation software is a plus.
Ability to report all work clearly and concisely to CTG on-site lead.
Excellent interpersonal skills and ability to work effectively and efficiently in a team-based environment with employees at all levels.
Requires the ability to work on-site five days each week, with the option of possible weekends.

Education:
Bachelor’s degree in Science or Engineering is preferred.
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