-
Computer Systems Validation Engineer III/IV
2 weeks ago
PCI Limited Bedford, United StatesLife 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 ...
-
Process Validation Engineer III
5 days ago
PCI Pharma Services Bedford, United StatesLife 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 ...
-
NH - Application Engineer IV
2 weeks ago
Zavda Technologies Manchester, United StatesNH - Application Engineer IV · Clearance: · US Citizen with TS/SCI with Poly · Certification: · IAT Level 2 Certification · Apply for this position: · Send a Microsoft Word copy of your resume to: · Zavda was founded in 2006 and is an SDB certified, Service Disabled Veter ...
-
engineer, controls iii
1 week ago
Barry-Wehmiller Companies Inc Manchester, United StatesAbout Us: · Machine Solutions is the premier provider of advanced equipment and services for the medical device, biopharmaceutical, and blood- and plasma-collection industries. We support our customers' needs and growth by delivering quality and value through a wide breadth of pr ...
-
Aews Program Engineering Manager Iii
1 week ago
BAE Systems Nashua, United StatesBecause of the need for consistent, in-person collaboration and/or the requirement to perform all work onsite due to the nature of this particular role, it will be performed full time on site. This means work will be conducted on location at a BAE Systems facility 100% of the tim ...
-
Engineer Controls III
2 weeks ago
Intec Automation, Inc. Manchester, United StatesIntec Automation, Inc., a well-established automation company with over 25 years of business experience, is seeking a Senior-level Controls Engineer to contribute to our continued growth. Located in Rochester, NH, we specialize in designing and constructing custom automation equi ...
-
Technical Support Engineer III
1 week ago
HealthSource of Ohio Loveland, United StatesIf you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process. · Technical Support Engineer III · Active - FT 40 full-time · Technical · Loveland, OH, US · 8 days ago · Requisition I ...
-
Systems Integration Engineer III
2 weeks ago
Idemia New Hampshire, United States Full time RegularResponsibilities · Support OK and MS Modernization projects and systems. · Responsible for maintaining system and be on all when scheduled. · Qualifications · Bachelor's degree · Technical system support experience · System adminsitration experience · ...
-
Engineer, Systems IV
2 weeks ago
Skylla Engineering North Charleston, United StatesABOUT: · Skylla Engineering is an agile and adaptive technology company that expeditiously delivers innovative solutions and knowledge-based services in support of the critical missions of our customers involved with the Nation's Defense. Skylla offers a highly competitive total ...
-
Engineer, Systems IV
2 weeks ago
Skylla North Charleston, United StatesJob Description · ABOUT: Skylla Engineering is an agile and adaptive technology company that expeditiously delivers innovative solutions and knowledge-based services in support of the critical missions of our customers involved with the Nation's Defense. Skylla offers a highly co ...
-
Engineer ElectricalElectronic IV
2 weeks ago
Long Island Community Hospital North Charleston, United StatesJob Description · ABOUT: Skylla Engineering is an agile and adaptive technology company that expeditiously delivers innovative solutions and knowledge-based services in support of the critical missions of our customers involved with the Nation's Defense. Skylla offers a highly c ...
-
Engineer, Systems IV
3 days ago
Skylla North Charleston, United StatesJob Description · ABOUT: · Skylla Engineering is an agile and adaptive technology company that expeditiously delivers innovative solutions and knowledge-based services in support of the critical missions of our customers involved with the Nation's Defense. Skylla offers a highl ...
-
Engineering Assistant IV
2 weeks ago
BAE Systems Nashua, United States Full timeJob Description Because of the need for consistent, in-person collaboration and/or the requirement to perform all work onsite due to the nature of this particular role, it will be performed full-time on site. This means work will be conducted on location at a BAE Systems facility ...
-
Engineer III
2 weeks ago
PDS Tech Commercial, Inc. Lowell, United StatesPDS Tech Commercial, Inc. is recruiting for an Engineer III in Lowell, MA. · Pay: $92 per hour · Contract Duration: 6 months · Shift: 100% onsite in Lowell, MA. Monday – Friday 8 am – 5 pm. · *Due to client regulations, all candidates for this role must have a US Citizen or U ...
-
Engineer Systems IV
2 weeks ago
Daytona State College North Charleston, United StatesIntro: · DAVIS Construction is the largest general contractor that solely serves the MidAtlantic region, with offices in Rockville, MD and Philadelphia, PA. Voted on by our employees, DAVIS has been consistently recognized as a Best Place to Work by the · Washington Business Jo ...
-
Engineer III
4 days ago
Evoqua Water Technologies Tewksbury, United StatesAbout Evoqua Water Technologies · We are excited to announce that Evoqua has now joined Xylem. By uniting our complementary approaches, products, and expertise, we enable our customers to dramatically improve the way water and wastewater is used, managed, conserved, re-used, and ...
-
Engineer, Electrical/Electronic IV
2 weeks ago
Skylla North Charleston, United StatesJob Description · Job Description · ABOUT: Skylla Engineering is an agile and adaptive technology company that expeditiously delivers innovative solutions and knowledge-based services in support of the critical missions of our customers involved with the Nation's Defense. Skyll ...
-
Electrical-Electronic Engineer IV
3 weeks ago
Predicate Logic North Charleston, United StatesJob Description · Job Description · Predicate Logic is looking for a motivated · Electrical-Electronic Engineer IV · to join our team in · Charleston, SC · supporting · Naval Information Warfare Center Atlantic (NIWC-A) . · Founded in 1992, Predicate Logic is a woman-owned ...
-
Engineer, Electrical/Electronic IV
2 weeks ago
Skylla Engineering North Charleston, United StatesTracking Code · Job Description · Job Description · ABOUT: Skylla Engineering is an agile and adaptive technology company that expeditiously delivers innovative solutions and knowledge-based services in support of the critical missions of our customers involved with the Nation' ...
-
Manufacturing Engineer III
1 week ago
Teleflex Chelmsford, United StatesThe Manufacturing Engineer III will have capability within engineering disciplines to support Manufacturing and Quality Compliance efforts throughout the business. Provide support as an engineering resource on cross functional teams focused on sustai Manufacturing Engineer, Conti ...
Computer Systems Validation Engineer III/IV - Bedford, United States - Packaging Coordinators Inc
Description
Computer Systems Validation Engineer III/IV page is loadedComputer Systems Validation Engineer III/IV
Apply
locations
Bedford, NH, USA
time type
Full time
posted on
Posted 8 Days Ago
job requisition id
JR106852
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 SUMMARY
The CSV Validation Engineer III/IV will write and assist in writing all validation deliverables within the Computer System Lifecycle, e.g.
Validation Plans, Summary Reports, Configuration Specifications.Responsible for developing and revising test validation procedures/protocols in accordance with appropriate regulatory agency validation requirements, 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 III/IV will review, generate system assessments, test scripts, change controls, process improvements and compliance governance at all applicable points of the system life cycle.
Collaborate with departments inside the organization to maintain and improve computer system validation processes to ensure robust, efficient, and compliant processes.
JOB DUTIES
Generate, review and approve local validation and compliance documents supporting GxP computerized systems, and relevant infrastructure, including those related to system procurement, audit, performance, compliance evaluation, and validation.
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 protocol execution, documentation of results, deviations, and corrective actions, and preparation of Summary Reports, Trace Matrices and Summary Reports associated to validated computer systemsPerform 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 including projects associated with PCS, BMS, CMS, OSI PI, and other automation 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 and QA Engineering.
Develop and maintain Validation SOPs, forms, documentation and files.
EDUCATION, PROFESSIONAL SKILLS, & EXPERIENCE
Five plus (5+) years of relevant automation, engineering, project management or operations experience within a cGMP environment, with at least 3 years of recent automation experience.
Computer systems experience with or for? manufacturing, equipment and process, as well as utilities, and facilities qualification.Experience in the biotechnology and/medical or pharmaceutical industry. Proficiency of Computers Systems Validation and Quality Systems.
Good knowledge and skills in engineering of Automation for HVAC/ Clean Media / Process Utility/Monitoring Building Management Systems including system
GMP compliance knowledge including knowledge of 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
PHYSICAL REQUIREMENTS
Must be able to sit or stand for prolonged periods of time
Must be able to travel between production facilities
COMMUNICATIONS & CONTACTS
Interacts with all departmental staff and other departments at all levels.
Ability to interface and communicate directly with clients may be required.
MANAGERIAL & SUPERVISORY RESPONSIBILITIES -
Not Applicable
#LI-LL1
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.
Similar Jobs (1)Computer Systems Validation Engineer IV
locations
Bedford, NH, USA
time type
Full time
posted on
Posted 8 Days Ago
About Us
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.
#J-18808-Ljbffr
