Commissioning, Qualification & Validation Engineer/Specialist
Commissioning, Qualification & Validation Engineer/Specialist
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Salary Not Disclosed
1 Vacancy
Job Description
Client is currently seeking a Commissioning/Validation Specialist/Engineer to work at one of 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 clients 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 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:
- Bachelors degree in Science or Engineering is preferred.
Employment Type
Full-time
