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.