CSV Engineer lV
Company: PCI Pharma Services
Location: Bedford
Posted on: April 1, 2026
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Job Description:
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. The CSV Validation
Engineer IV is responsible for authoring and reviewing validation
deliverables within the Computer System Lifecycle (e.g. Validation
Plans, SOPs, Protocols, Trace Matrix, Assessments, and Reports).
Participate in developing and revising validation procedures and
protocols to meet regulatory requirements and site quality and
validation procedures. corporate & site quality management system
and current industry practices. Interact with CSV Management to
prioritize and/or harmonize activities. Participate in multi-site
CSV initiatives through document development or other validation
activities. The CSV Validation Engineer IV is responsible for
authoring, reviewing and approving system assessments, test
documents, change controls, process improvements and compliance
governance at all applicable points of the system life cycle for
all PCI sites. In addition, this individual will serve as the SME
to provide compliance leadership and oversight for CSV projects.
Collaborate with departments -within the organization to maintain
and improve computerized system validation processes to ensure
robust, efficient, and compliant processes. JOB DUTIES Generate,
review and approve local validation and compliance documents
supporting GxP computerized and computer systems, and relevant
infrastructure. Provide support for SOPs, qualification protocols,
gap assessments, risk assessment, Impact Assessment, user
requirements, functional and configuration specifications,
requirements traceability, validation plans, validation summary
reports and change controls. Execute validation protocols; assists
in deviations and corrective actions plans; and write reports,
trace matrices; and assists in system SOP updates to ensure system
is complaint and operates per intended use. Perform Gap Assessments
and Remediation Plans with an understanding of applying risk
management principles. Ensure appropriate regulations, such as 21
CFR Part 11, 820 and cGMP regulations, are addressed in validation.
Performs periodic reviews and ongoing support of validated systems
post Go-Live. Perform revalidation and change control validation
related activities. Ability to apply complex system validation
principles to work assignments. Responsible for executing and
reviewing control systems validation activities, and other
system/equipment upgrades. Assess the impact of system changes thru
change management and change control systems; participate in the
planning and implementation of change. Provide training to
colleagues and contractors on our approach to systems
implementation and validation SOP's. Assist validation activities
of cross functional teams that include technical functions such as
Information Systems, Manufacturing, Quality Control, and
Engineering. Develop and maintain Validation SOPs, and forms.
EDUCATION, PROFESSIONAL SKILLS, & EXPERIENCE Ten plus (10) years of
relevant computer systems validation, project management or
operations experience within a cGMP environment, with at least 5
years of recent validation/engineering experience. Computer systems
validation experience for GMP manufacturing, laboratory, quality,
as well as utilities, and facilities. Experience in the
biotechnology and/medical or pharmaceutical industry. Proficiency
of Computers Systems Validation and Quality Systems. Good
understanding of software supporting automated systems, laboratory
equipment, and quality systems. Knowledge regulatory guidelines
including 21 CFR Parts 11, 210, 211, and 820 requirements, Data
Integrity, ICH Q7A requirements, and GAMP Experience in thorough
testing of applications, computerized systems, changes and
implementations. Excellent written and oral communication to
include accurate and legible documentation skills. Ability to work
in a fast-paced environment. Team oriented. Independent work skills
and a strong work ethic. Microsoft Office and database management
skills. Ability to handle multiple projects LI-AK2 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.
Keywords: PCI Pharma Services, Newton , CSV Engineer lV, Engineering , Bedford, Massachusetts
