PCI Pharma Services
Cleaning Validation Engineer III
PCI Pharma Services, San Diego, California, United States, 92189
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Cleaning Validation Engineer III
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PCI Pharma Services Why work for PCI Pharma Services?
At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. Job Details
We are currently seeking a Cleaning Validation Engineer III who plays a critical role in ensuring that cleaning validation activities within commercial and clinical fill and finish facilities are compliant with both internal and regulatory standards. Responsibilities
Leads and executes cleaning validation studies, ensuring all activities are in compliance with FDA, EMA, and other relevant regulatory standards. Performs comprehensive risk assessments related to cross-contamination and GMP risks. Prepares, executes, and reports on cleaning validation testing across various phases of commissioning and qualification. Assesses the adequacy of existing cleaning methods, ensuring they are suitable for intended use, especially with respect to contamination levels. Analyzes cleaning validation data, including rinse and swab results, and identifies corrective actions where necessary. Works closely with teams across manufacturing, quality assurance, quality control, and engineering to define cleaning validation requirements and ensure adherence to project timelines. Ensures compliance with site EHS policies, cGMP regulations, and the company's Quality Management System (QMS). Requirements
Bachelors degree in Engineering, Chemical Engineering, Biochemistry, Microbiology, Chemistry, or a related field, required Minimum of 5 years of experience in cleaning validation in the pharmaceutical and biotechnology industries. Experience in at least three of the following areas: C&Q validation, Cleaning Validation, Equipment validation, Process operations or manufacturing, Process Engineering. Knowledge of regulatory requirements such as FDA, cGMP, and industry guidelines related to cleaning validation. Strong understanding of validation principles and practices for cleaning processes and equipment. Excellent communication and collaboration skills. The base hourly range for this position is $105,635.08 - $138,646.04 USD plus annual performance bonus eligibility. Equal Employment Opportunity (EEO) Statement
PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
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Cleaning Validation Engineer III
role at
PCI Pharma Services Why work for PCI Pharma Services?
At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. Job Details
We are currently seeking a Cleaning Validation Engineer III who plays a critical role in ensuring that cleaning validation activities within commercial and clinical fill and finish facilities are compliant with both internal and regulatory standards. Responsibilities
Leads and executes cleaning validation studies, ensuring all activities are in compliance with FDA, EMA, and other relevant regulatory standards. Performs comprehensive risk assessments related to cross-contamination and GMP risks. Prepares, executes, and reports on cleaning validation testing across various phases of commissioning and qualification. Assesses the adequacy of existing cleaning methods, ensuring they are suitable for intended use, especially with respect to contamination levels. Analyzes cleaning validation data, including rinse and swab results, and identifies corrective actions where necessary. Works closely with teams across manufacturing, quality assurance, quality control, and engineering to define cleaning validation requirements and ensure adherence to project timelines. Ensures compliance with site EHS policies, cGMP regulations, and the company's Quality Management System (QMS). Requirements
Bachelors degree in Engineering, Chemical Engineering, Biochemistry, Microbiology, Chemistry, or a related field, required Minimum of 5 years of experience in cleaning validation in the pharmaceutical and biotechnology industries. Experience in at least three of the following areas: C&Q validation, Cleaning Validation, Equipment validation, Process operations or manufacturing, Process Engineering. Knowledge of regulatory requirements such as FDA, cGMP, and industry guidelines related to cleaning validation. Strong understanding of validation principles and practices for cleaning processes and equipment. Excellent communication and collaboration skills. The base hourly range for this position is $105,635.08 - $138,646.04 USD plus annual performance bonus eligibility. Equal Employment Opportunity (EEO) Statement
PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
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