PCI Pharma Services
Sr. Validation Engineer, CSV
PCI Pharma Services - San Diego, California, United States, 92189
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Overview
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Sr. Validation Engineer, CSV
role at
PCI Pharma Services 2 weeks ago Be among the first 25 applicants Join to apply for the
Sr. Validation Engineer, CSV
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. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don’t say no, we figure out how. 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. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don’t say no, we figure out how.
Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
We are PCI.
Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
Job Details
This position authors, executes, reviews and approves computer systems validation projects as directed by management. Acts as a CSV SME. Validates and qualifies complex computerized systems and software platforms for GxP use. Review's change control for validated systems and may train lower-level personnel.
Responsibilities
Documentation Preparation (Validation plans, User Requirement Specifications, Functional Specifications, Risk Assessments, Traceability Matrices, Protocol and Report Generation). Protocol Execution. Change Control validation assessments for Computerized Systems. Annual evaluation of GMP Computerized Systems. Training personnel in CSV practices. 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 or Information Technology (IT) discipline or equivalent experience required. Minimum of eight (8) years of relevant experience in IT, quality, validation, or process engineering. GxP hardware and/or software experience required. Strong background in IT systems and strong knowledge of cGMP and validation regulations and requirements. Knowledge of GMP, GLP, GDP, pharmacopoeial and regulatory requirements. Detail oriented with strong written and verbal communication skills. Ability to work independently, within prescribed guidelines, or as a team member.
The base hourly range for this position is $106,800 to $120,150 USD 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
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.
#HP
Seniority level
Seniority level Mid-Senior level Employment type
Employment type Full-time Job function
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Sr. Validation Engineer, CSV
role at
PCI Pharma Services 2 weeks ago Be among the first 25 applicants Join to apply for the
Sr. Validation Engineer, CSV
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. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don’t say no, we figure out how. 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. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don’t say no, we figure out how.
Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
We are PCI.
Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
Job Details
This position authors, executes, reviews and approves computer systems validation projects as directed by management. Acts as a CSV SME. Validates and qualifies complex computerized systems and software platforms for GxP use. Review's change control for validated systems and may train lower-level personnel.
Responsibilities
Documentation Preparation (Validation plans, User Requirement Specifications, Functional Specifications, Risk Assessments, Traceability Matrices, Protocol and Report Generation). Protocol Execution. Change Control validation assessments for Computerized Systems. Annual evaluation of GMP Computerized Systems. Training personnel in CSV practices. 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 or Information Technology (IT) discipline or equivalent experience required. Minimum of eight (8) years of relevant experience in IT, quality, validation, or process engineering. GxP hardware and/or software experience required. Strong background in IT systems and strong knowledge of cGMP and validation regulations and requirements. Knowledge of GMP, GLP, GDP, pharmacopoeial and regulatory requirements. Detail oriented with strong written and verbal communication skills. Ability to work independently, within prescribed guidelines, or as a team member.
The base hourly range for this position is $106,800 to $120,150 USD 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
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.
#HP
Seniority level
Seniority level Mid-Senior level Employment type
Employment type Full-time Job function
Job function Quality Assurance Industries Pharmaceutical Manufacturing Referrals increase your chances of interviewing at PCI Pharma Services by 2x Get notified about new Senior Validation Engineer jobs in
San Diego, CA . Senior Quality Engineer - Risk Management (Remote)
Senior Staff Quality Engineer (Strong Medical Device Exp) Onsite
San Diego, CA $114,750.00-$205,632.00 15 hours ago Sr Quality Engineer, Software - Design Controls
Sr. Software Quality Engineer (Cybersecurity)
Sr. Software Engineer - Payments Support
Senior Principal Engineer Software - Tenant Solutions Architect (San Diego CA) - R10201652
Sr Quality Engineer [Must Have Validation, Nonconformance and CAPA]
Senior Quality Engineer - Risk Management (Remote) Exp in Regulated Industry
Senior Supplier Quality Engineer - Electronics (PCB, PCBA)
San Diego Metropolitan Area $108,000.00-$116,000.00 19 hours ago Quality Engineer, Technical Investigation
Staff Process Engineer/ Quality Systems Engineer - Remote
San Diego, CA $81,080.00-$141,650.00 22 hours ago Senior Manufacturing Engineer - Quality Engineering
Validation Engineer Exp with biological equipment validation exp min 5 yrs of pure validation Onsite
We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr