ZipRecruiter
REMOTE Quality Engineer, Cleaning Validation SME - 21498
ZipRecruiter, San Diego, California, United States, 92189
Overview
REMOTE Quality Engineer, SME - Simply Biotech
Are you looking for a new career opportunity with an exciting biotech company? In this role, you are responsible for the duties listed below.
Immediate opening for a
REMOTE Quality Engineer, SME
with a biotech company in
San Diego, CA
for applicants who exclusively possess:
An advanced degree ( M.S., or Ph.D. ) in Analytical Chemistry, Pharmaceutical Sciences, or a related field.
3+ years of industry analytical method development to support cleaning validation
Direct experience with swab recovery studies for cleaning validation
Proven hands-on experience with LC-MS, HPLC, and TOC testing.
Must be able to travel to South Korea for implementation in January
Email resumes to
jgarcia@simplybiotech.com
or call 858.279.4902
Full Description We are seeking an experienced Quality Control Subject Matter Expert (QC SME) to support a project focused on cleaning validation for small-molecule biopharmaceutical manufacturing. The role requires expertise in analytical methods such as LC-MS, HPLC, and TOC, as well as cleaning verification laboratory studies using industry-standard techniques. All project-related expenses will be covered in accordance with the client's policies.
The selected candidate will be responsible for:
Design and execute cleaning swab recovery studies for small-molecule products using a representative surrogate and cytotoxic payload, following existing template protocols.
Understand analytical test methods such as LC-MS, HPLC, and TOC for swabs.
Qualify representative surrogate compounds using USP/EU Compendial test methods for cleaning validation programs.
Generate and review protocols, reports, and supporting documentation using client template protocols and report formats that align with FDA, EMA, and PIC/S expectations.
Collaborate with site teams in South Korea to conduct onsite laboratory and validation activities.
Provide remote technical support for protocol development and summary report writing, and support the execution of swab and recovery studies onsite.
The selected candidate will also possess:
An advanced degree (B.S., M.S., or Ph.D.) in Analytical Chemistry, Pharmaceutical Sciences, or a related field.
5+ years of experience in analytical method validation and cleaning verification.
Proven hands-on experience with LC-MS, HPLC, and TOC testing.
Direct experience with swab recovery studies for cleaning validation.
Familiarity with global regulatory guidelines (FDA, EMA, ICH, PIC/S).
Strong technical writing and documentation skills.
Availability to travel and work onsite in South Korea for at least one month during the assignment.
Salary Range: $65/hr
For immediate and confidential consideration, please email your resume to
jgarcia@simplybiotech.com
or call 858.279.4902. More information can be found at
www.simplybiotech.com
#J-18808-Ljbffr
Are you looking for a new career opportunity with an exciting biotech company? In this role, you are responsible for the duties listed below.
Immediate opening for a
REMOTE Quality Engineer, SME
with a biotech company in
San Diego, CA
for applicants who exclusively possess:
An advanced degree ( M.S., or Ph.D. ) in Analytical Chemistry, Pharmaceutical Sciences, or a related field.
3+ years of industry analytical method development to support cleaning validation
Direct experience with swab recovery studies for cleaning validation
Proven hands-on experience with LC-MS, HPLC, and TOC testing.
Must be able to travel to South Korea for implementation in January
Email resumes to
jgarcia@simplybiotech.com
or call 858.279.4902
Full Description We are seeking an experienced Quality Control Subject Matter Expert (QC SME) to support a project focused on cleaning validation for small-molecule biopharmaceutical manufacturing. The role requires expertise in analytical methods such as LC-MS, HPLC, and TOC, as well as cleaning verification laboratory studies using industry-standard techniques. All project-related expenses will be covered in accordance with the client's policies.
The selected candidate will be responsible for:
Design and execute cleaning swab recovery studies for small-molecule products using a representative surrogate and cytotoxic payload, following existing template protocols.
Understand analytical test methods such as LC-MS, HPLC, and TOC for swabs.
Qualify representative surrogate compounds using USP/EU Compendial test methods for cleaning validation programs.
Generate and review protocols, reports, and supporting documentation using client template protocols and report formats that align with FDA, EMA, and PIC/S expectations.
Collaborate with site teams in South Korea to conduct onsite laboratory and validation activities.
Provide remote technical support for protocol development and summary report writing, and support the execution of swab and recovery studies onsite.
The selected candidate will also possess:
An advanced degree (B.S., M.S., or Ph.D.) in Analytical Chemistry, Pharmaceutical Sciences, or a related field.
5+ years of experience in analytical method validation and cleaning verification.
Proven hands-on experience with LC-MS, HPLC, and TOC testing.
Direct experience with swab recovery studies for cleaning validation.
Familiarity with global regulatory guidelines (FDA, EMA, ICH, PIC/S).
Strong technical writing and documentation skills.
Availability to travel and work onsite in South Korea for at least one month during the assignment.
Salary Range: $65/hr
For immediate and confidential consideration, please email your resume to
jgarcia@simplybiotech.com
or call 858.279.4902. More information can be found at
www.simplybiotech.com
#J-18808-Ljbffr