PCI Pharma Services
Process Validation Engineer I
PCI Pharma Services, San Diego, California, United States, 92189
Overview
The Process Validation Engineer I collaborates with product sponsors to develop process validation programs for each drug product in accordance with the applicable guidance documents. These documents include, but are not limited to, validation master plans, risk assessments, process performance qualification (PPQ) protocols & reports, and continued process verification plans (CPV). Responsibilities
Under the guidance of senior team members, works with clients to develop process validation programs suitable for the applicable drug product(s). Authors and collaborates on product specific validation master plans for each drug product to describe the process validation (PV) philosophy and approach in demonstrating capabilities related to the manufacturing of drug products under the guidance of senior team members. Uses risk assessment tools to evaluate the risks and required mitigation plans associated with the validation of each drug product. Under the guidance of senior team members, may author and collaborate on PPQ protocols and summary reports to describe the procedures, methods, acceptance criteria, and sampling plan required to provide evidence that the drug product processes are reproducible, consistently produce product that meet their quality attributes, and are in a state of control. Responsible for evaluating product and process data to provide ongoing assurance that the drug product manufacturing processes remain in a validated state during commercial manufacturing. Writes and reviews Standard Operating Procedures (SOPs) related to qualification activities. Works closely with cross-functional departments as necessary to resolve issues. Regular and reliable attendance on a full-time basis [or in accordance with posted schedule]. Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company’s policies and practices. Embodies PCI Pharma Services cultural values and aligns daily actions with department goals and company culture. Requirements
Bachelor’s degree in a Life Sciences discipline or equivalent experience required. Minimum of 0-2 years of relevant experience in validation or process engineering. Strong knowledge of industry guidance documents pertaining to process validation (including, but not limited to FDA guidance for process validation and Annex 15) preferred. Detail oriented and strong written and verbal communication skills. Ability to work independently, within prescribed guidelines, or as a team member. Experience with Microsoft Office applications. The base hourly range for this position is $68,640 to $77,040 plus annual performance bonus eligibility. Final offer amounts are determined by multiple factors including and not limited to specific and relevant experience, credentials, geography and subject matter expertise. Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future For Los Angeles applicants, we abide by the Fair Chance Initiative for Hiring. Learn more about the policy here: FCIHO 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. At PCI, Equity and Inclusion are at the core of our company’s purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity – at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture. Seniority level
Entry level Employment type
Full-time Job function
Quality Assurance Industries Pharmaceutical Manufacturing
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The Process Validation Engineer I collaborates with product sponsors to develop process validation programs for each drug product in accordance with the applicable guidance documents. These documents include, but are not limited to, validation master plans, risk assessments, process performance qualification (PPQ) protocols & reports, and continued process verification plans (CPV). Responsibilities
Under the guidance of senior team members, works with clients to develop process validation programs suitable for the applicable drug product(s). Authors and collaborates on product specific validation master plans for each drug product to describe the process validation (PV) philosophy and approach in demonstrating capabilities related to the manufacturing of drug products under the guidance of senior team members. Uses risk assessment tools to evaluate the risks and required mitigation plans associated with the validation of each drug product. Under the guidance of senior team members, may author and collaborate on PPQ protocols and summary reports to describe the procedures, methods, acceptance criteria, and sampling plan required to provide evidence that the drug product processes are reproducible, consistently produce product that meet their quality attributes, and are in a state of control. Responsible for evaluating product and process data to provide ongoing assurance that the drug product manufacturing processes remain in a validated state during commercial manufacturing. Writes and reviews Standard Operating Procedures (SOPs) related to qualification activities. Works closely with cross-functional departments as necessary to resolve issues. Regular and reliable attendance on a full-time basis [or in accordance with posted schedule]. Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company’s policies and practices. Embodies PCI Pharma Services cultural values and aligns daily actions with department goals and company culture. Requirements
Bachelor’s degree in a Life Sciences discipline or equivalent experience required. Minimum of 0-2 years of relevant experience in validation or process engineering. Strong knowledge of industry guidance documents pertaining to process validation (including, but not limited to FDA guidance for process validation and Annex 15) preferred. Detail oriented and strong written and verbal communication skills. Ability to work independently, within prescribed guidelines, or as a team member. Experience with Microsoft Office applications. The base hourly range for this position is $68,640 to $77,040 plus annual performance bonus eligibility. Final offer amounts are determined by multiple factors including and not limited to specific and relevant experience, credentials, geography and subject matter expertise. Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future For Los Angeles applicants, we abide by the Fair Chance Initiative for Hiring. Learn more about the policy here: FCIHO 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. At PCI, Equity and Inclusion are at the core of our company’s purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity – at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture. Seniority level
Entry level Employment type
Full-time Job function
Quality Assurance Industries Pharmaceutical Manufacturing
#J-18808-Ljbffr