CrawlJobs Logo

CSV Engineer IV

pci.com Logo

PCI Pharma Services

Location Icon

Location:
United States , Bedford

Category Icon
Category:
IT - Administration

Job Type Icon

Contract Type:
Not provided

Salary Icon

Salary:

Not provided
Save Job
Save Icon
Apply Position

Job Description:

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 Responsibility:

  • Author and review 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
  • Interact with CSV Management to prioritize and/or harmonize activities
  • Participate in multi-site CSV initiatives through document development or other validation activities
  • Author, review and approve system assessments, test documents, change controls, process improvements and compliance governance at all applicable points of the system life cycle for all PCI sites
  • 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
  • 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
  • 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

Requirements:

  • 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

Additional Information:

Job Posted:
February 20, 2026

Employment Type:
Fulltime
Work Type:
On-site work
Icon
PCI Pharma Services - All Job Offers
Job Link Share:
Copy Link Icon
Facebook Icon Twitter Icon LinkedIn Icon

Looking for more opportunities? Search for other job offers that match your skills and interests.

Briefcase Icon

Similar Jobs for CSV Engineer IV

Support Worker

Support Worker role in a specialist Supported Living and Outreach service in St ...
Location
Location
United Kingdom , St Austell, Cornwall
Salary
Salary:
13.45 - 14.05 GBP / Hour
accomplish-group.co.uk Logo
Accomplish
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Must be over the age of 18
  • Experience within the care sector is not needed as full training is offered
Job Responsibility
Job Responsibility
  • Day-to-day support and routine of the people we support
  • Prompting independence whilst helping them live a fulfilling life
  • Supporting & encouraging the development of personal skills through hobbies and interests
  • Maintaining and helping with health care needs, including accompanying the people we support to routine appointments or administrating medication
  • Teaching life skills such as budgeting, paying bills & shopping
  • Assisting with personal care as required
  • Assisting with domestic tasks including cleaning & cooking
  • Providing guidance & encouragement through physical & emotional support
What we offer
What we offer
  • Annual Leave - 5.6 weeks of annual leave inclusive of 8 public holidays
  • DBS Check Paid
  • Qualifications & Career Development - support for QCF qualifications
  • Circle - hub for wellbeing, engagement and discounts
  • Amazing Discount Scheme via Blue Light card
  • NEST Pension Scheme with matched contribution of up to 3%
  • Fair & Competitive Pay as a Real Living Wage Employer
  • £500 Referral Bonus
  • Full Induction & Introductory Programme
  • Fulltime
Read More
Arrow Right

Hospitality Worker II - Front Desk

The Hospitality Worker II - Front Desk agent is responsible for ensuring guest s...
Location
Location
United States , Bowie
Salary
Salary:
20.07 USD / Hour
aramark.com Logo
Aramark
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Previous guest services experience required
  • Previous cash handling experience preferred
  • Demonstrates excellent customer service skills
  • Demonstrates interpersonal and communication skills, both verbal and written
  • Demonstrate organizational skills, accuracy, and attention to detail
  • Minimum 1-2 years experience
  • High School Diploma
Job Responsibility
Job Responsibility
  • Greet and provide customer service to guests while anticipating their needs
  • Supply guests or travelers with directions, travel information, and other information such as available services and points of interest
  • Book reservations, rentals, and coordinate registration
  • Operate a register and/or software system to complete cash and credit card transactions
  • Answers phone calls and emails and delivers messages as needed
  • Maintains excellent customer service and positive attitude towards guest, customers, clients, co-workers, etc
  • Coordinate resolution of guest concerns
  • Communicates closely with all departments to ensure a seamless guest experience
What we offer
What we offer
  • medical
  • dental
  • vision
  • work/life resources
  • retirement savings plans like 401(k)
  • paid days off, such as parental leave and disability coverage
  • Parttime
Read More
Arrow Right

Registered Nurse - Case Manager

In partnership with the primary care provider, (PCP), the RN, Case Manager is th...
Location
Location
United States , Cleveland
Salary
Salary:
60522.00 - 129615.00 USD / Year
https://www.cvshealth.com/ Logo
CVS Health
Expiration Date
June 30, 2026
Flip Icon
Requirements
Requirements
  • Current RN license in assigned state is required
  • Bachelor degree in nursing preferred
  • Minimum of 6-8 years nursing experience
  • Certified Case Manager (CCM) required, or willingness to obtain within 12 months of hire, unless candidate has 2-3 years of relevant care/case management experience
  • 2+ years experience in transitional nursing, emergency room nursing, care coordination, discharge planning, or home health is strongly preferred
  • Demonstrated skill in motivational interviewing, patient activation, time management, and navigating community and social resources
  • A flexible and positive attitude
  • Comfort with ambiguity and change
  • High emotional intelligence as evidenced by ability to evaluate/perceive a situation from multiple lenses and understand various perspectives in coming to problem resolution
  • Access to reliable transportation and ability to travel throughout the communities OSH serves
Job Responsibility
Job Responsibility
  • Manages an assigned caseload of complex patients in a value-based care environment, with a focus on driving reduced admissions, readmissions, and medical utilization
  • Accountable for panel metric performance in admission prevention, readmission prevention, and transitions of care metrics
  • Owns overall care coordination for assigned patients, functioning as the primary point of contact and ensuring alignment, accountability, and follow-through across the care team
  • Manage transitions of care episodes for patients on their panel, including timely completion of structured clinical assessments to identify post-discharge needs, medication reconciliation on behalf of the PCP, and addressal of identified needs directly or via collaboration with other team members
  • Collaborates patient’s PCP, family/caregiver, Social Worker, Behavioral Health Specialists, and other care team members, as needed to evaluate the individual's needs, goals, and plan of action and ensure care plan progression
  • Ensure timely documentation of key clinical assessments after admissions, while balancing in-center care team planning meetings
  • Lead in-person interdisciplinary care planning meetings to ensure effective care coordination and management between providers visits
  • Perform timely nursing assessments and provide patient education for chronic condition management and transitions of care
  • Educate patients and families, empowering them in their care, and advocating for their needs
  • Document visits in electronic health record according to internal standards
What we offer
What we offer
  • Paid vacation, sick time, and investment/retirement 401K match options
  • Health insurance, vision, and dental benefits
  • Opportunities for leadership development and continuing education stipends
  • New centers and flexible work environments
  • Opportunities for high levels of responsibility and rapid advancement
  • Affordable medical plan options, a 401(k) plan (including matching company contributions), and an employee stock purchase plan
  • No-cost programs for all colleagues including wellness screenings, tobacco cessation and weight management programs, confidential counseling and financial coaching
  • Benefit solutions that address the different needs and preferences of our colleagues including paid time off, flexible work schedules, family leave, dependent care resources, colleague assistance programs, tuition assistance, retiree medical access and many other benefits depending on eligibility
  • Fulltime
Read More
Arrow Right

Senior Engineer - Civil

Reinforcement Engineer:
Location
Location
India , Bengaluru
Salary
Salary:
Not provided
larsentoubro.com Logo
Larsen & Toubro
Expiration Date
September 19, 2026
Flip Icon
Requirements
Requirements
  • 3 - 7 Years experience
  • Knowledge of BAR BENDING SCHEDULE
  • Minimum Qualification B.TECH/B.E
  • Minimum Qualification GRADUATE DIPLOMA
Job Responsibility
Job Responsibility
  • Reporting to the Casting Yard Project Manager
  • Responsible for Cutting, Bending & Tying of reinforcement cages for segments
  • Interacting with Engineer’s representatives and internal departments
  • Preparation of BBS based on approved drawings
  • Optimization of Scrap & Offcuts
  • Safe working condition and safe acts of all workers, machineries etc.
  • Quality to be ensured at all stages
  • Submission of requirement of steel on monthly basis to the Construction Manager
  • Co-ordination between the shift engineers
  • RFI submission as per the systems according to the activities planned
Read More
Arrow Right

Electrical Engineer

Electrical Engineer
Location
Location
India , Powai
Salary
Salary:
Not provided
larsentoubro.com Logo
Larsen & Toubro
Expiration Date
September 20, 2026
Flip Icon
Requirements
Requirements
  • Knowledge of high-voltage systems including Gas insulated switchgear, Transformers, reactors, etc.
  • Knowledge of Low voltage systems, including UPS systems, cable sizing, etc.
  • Knowledge of electrical engineering software such as ETAP, etc.
  • Minimum Qualification: BACHELOR OF ENGINEERING (BE)
  • Required Experience: 5 - 35 Years
  • Skills: ENGINEERING MANAGEMENT
Job Responsibility
Job Responsibility
  • Provide technical support to the design team developing the engineering solution
  • Develop engineering solutions to problems that reflect constructability and operability issues
  • Prepare and check engineering calculations and drawings on the project team
  • Support the preparation of project specifications, requisitions, and reports
  • Guide a team of electrical engineers & designers for the complete project/engineering cycle
  • Coordination with the engineering contractor or LTEH Engineering department and client for comment resolution and approval
Read More
Arrow Right

Support Worker

Our specialist Supported Living and Outreach services in Beaconsfield provides s...
Location
Location
United Kingdom , Beaconsfield
Salary
Salary:
12.60 - 13.30 GBP / Hour
accomplish-group.co.uk Logo
Accomplish
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • UK Drivers License required
  • Female support worker due to genuine occupational requirement
  • Must be over the age of 18
  • Positive attitude & passionate about supporting adults with learning disabilities
  • Can demonstrate a practical understanding of delivering support with dignity, privacy and respect
Job Responsibility
Job Responsibility
  • Promoting and delivering a person-centred support culture across the service
  • Supporting people with all aspects of their daily living as per their support plan, this will include personal care and taking their medication
  • Supporting and coaching people to learn independent living skills like cooking and laundry tasks
  • Supporting people to access the community for social, educational or employment opportunities
  • Safeguarding service users’ rights and dignity
  • Taking an active role in peoples support plans and risk assessment’s
  • Provide effective communication within the team and attending regular team & service user meetings
  • To liaise professionally with family members and other professionals
What we offer
What we offer
  • Annual Leave - Enjoy 5.6 weeks of annual leave inclusive of 8 public holidays
  • DBS Check Paid
  • Qualifications & Career Development - support for QCF qualifications
  • Circle - hub for wellbeing, engagement and discounts
  • Amazing Discount Scheme via Blue Light card
  • NEST Pension Scheme with matched contribution of up to 3%
  • Fair & Competitive Pay as a Real Living Wage Employer
  • £500 Referral Bonus
  • Full Induction & Introductory Programme
  • Fulltime
Read More
Arrow Right

Procurement Specialist - Red Meat

Optimise revenue by analysing carcass optimisation against market procurement op...
Location
Location
Australia , Norwest Sydney
Salary
Salary:
Not provided
woolworths.com.au Logo
Woolworths Supermarkets
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Minimum 5 years of experience in a similar procurement, buying, or commercial role
  • Extensive background and experience within the Red Meat industry is essential
  • Import and/or Export experience highly regarded
  • Demonstrated skills in matrix management, influencing, and collaborating
  • Critical thinking and analysis skills with the ability to engage all levels of management
  • Expert computer skills, including MS Office Suite, Google, Tableau, and CRM systems
  • Certified Meat Processing qualifications are an advantage but not essential
Job Responsibility
Job Responsibility
  • Develop optimal purchasing plans aligned with internal supply chain and customer needs
  • Manage the full procurement lifecycle, including tendering timelines, purchase orders, and compliance
  • Perform carcass optimisation planning to ensure maximum profitability and efficiency
  • Proactively communicate procurement strategies to drive a culture of operational excellence
  • Keep abreast of key trends, market values, and competitor landscapes
  • Build and develop strong stakeholder relationships both internally and Externally
  • Review and analyse data insights, translating market intelligence into actionable insights and recommendations
What we offer
What we offer
  • A hybrid working model combining time at our Norwest Support Office and working from home
  • A global business with career opportunities across every discipline and valuable business exposure
  • 24/7 access to the Sonder app for personalised safety, medical, and psychological support
  • Savings across Woolworths Group brands and a rewards program that celebrates purpose-driven work
  • A progressive leave policy that gives you more space for what matters to you
Read More
Arrow Right

Registered Nurse Case Manager

We’re building a world of health around every individual — shaping a more connec...
Location
Location
United States , Burton
Salary
Salary:
60522.00 - 129615.00 USD / Year
https://www.cvshealth.com/ Logo
CVS Health
Expiration Date
June 30, 2026
Flip Icon
Requirements
Requirements
  • Current RN license in assigned state is required
  • Bachelor degree in nursing preferred
  • Minimum of 6-8 years nursing experience
  • Certified Case Manager (CCM) required, or willingness to obtain within 12 months of hire, unless candidate has 2-3 years of relevant care/case management experience
  • 2+ years experience in transitional nursing, emergency room nursing, care coordination, discharge planning, or home health is strongly preferred
  • Demonstrated skill in motivational interviewing, patient activation, time management, and navigating community and social resources
  • A flexible and positive attitude
  • Comfort with ambiguity and change
  • High emotional intelligence as evidenced by ability to evaluate/perceive a situation from multiple lenses and understand various perspectives in coming to problem resolution
  • Access to reliable transportation and ability to travel throughout the communities OSH serves
Job Responsibility
Job Responsibility
  • Manages an assigned caseload of complex patients in a value-based care environment, with a focus on driving reduced admissions, readmissions, and medical utilization
  • Accountable for panel metric performance in admission prevention, readmission prevention, and transitions of care metrics
  • Owns overall care coordination for assigned patients, functioning as the primary point of contact and ensuring alignment, accountability, and follow-through across the care team
  • Manage transitions of care episodes for patients on their panel, including timely completion of structured clinical assessments to identify post-discharge needs, medication reconciliation on behalf of the PCP, and addressal of identified needs directly or via collaboration with other team members
  • Collaborates patient’s PCP, family/caregiver, Social Worker, Behavioral Health Specialists, and other care team members, as needed to evaluate the individual's needs, goals, and plan of action and ensure care plan progression
  • Ensure timely documentation of key clinical assessments after admissions, while balancing in-center care team planning meetings
  • Lead in-person interdisciplinary care planning meetings to ensure effective care coordination and management between providers visits
  • Perform timely nursing assessments and provide patient education for chronic condition management and transitions of care
  • Educate patients and families, empowering them in their care, and advocating for their needs
  • Document visits in electronic health record according to internal standards
What we offer
What we offer
  • Mission-focused career impacting change and measurably improving health outcomes for Medicare patients
  • Paid vacation, sick time, and investment/retirement 401K match options
  • Health insurance, vision, and dental benefits
  • Opportunities for leadership development and continuing education stipends
  • New centers and flexible work environments
  • Opportunities for high levels of responsibility and rapid advancement
  • Affordable medical plan options, a 401(k) plan (including matching company contributions), and an employee stock purchase plan
  • No-cost programs for all colleagues including wellness screenings, tobacco cessation and weight management programs, confidential counseling and financial coaching
  • Benefit solutions that address the different needs and preferences of our colleagues including paid time off, flexible work schedules, family leave, dependent care resources, colleague assistance programs, tuition assistance, retiree medical access and many other benefits depending on eligibility
  • Fulltime
Read More
Arrow Right
Remote jobs Jobs by Category
Art and Entertainment Jobs Banking Jobs Call Center Jobs Construction Jobs Consulting Jobs Customer Service Jobs Education Jobs Energy Jobs Finance Jobs Gastronomy Jobs Health and Beauty Jobs Hospitality and Tourism Jobs Human Resources Jobs Insurance Jobs IT - Administration Jobs IT - Software Development Jobs Legal Jobs Logistics Jobs Manufacturing Jobs Marketing, Digital Marketing, SEO, SEM Jobs Media Jobs Nursing Jobs Office Administration Jobs Pharmacy Jobs Physical Work Jobs Public Relations Jobs Public Sector Jobs Purchasing Jobs Quality Control Jobs Real Estate Jobs Research and Development Jobs Sales Jobs
Job Positions Jobs by Country
United States Jobs United Kingdom Jobs India Jobs Canada Jobs Australia Jobs Germany Jobs Ireland Jobs Poland Jobs
Company
Blog Salaries About Us Contact
Follow Us
Facebook
X (Twitter)
LinkedIn
Instagram
CrawlJobs Group
ITFlashcards AllDevBlogs
© 2026 CrawlJobs Ltd. All Rights Reserved
Terms & Conditions Privacy Policy