Computer Systems Validation and Qualification Engineer
Company: Disability Solutions
Location: Chelsea
Posted on: October 3, 2024
Job Description:
CSV and Qualification EngineerPosition Summary:Catalent is a
global, high-growth, public company and a leading partner for the
pharmaceutical industry in the development and manufacturing of new
treatments for patients worldwide. Your talents, ideas, and passion
are essential to our mission: to help people live better, healthier
lives.--The Boston-area facility is Catalent's global Center of
Excellence for spray dry dispersion and Dry Powder Inhaler (DPI)
capsule manufacture and packaging. The site features inhaled powder
spray drying, as well as multiple commercial-scale lines for
capsule filling and blister packaging. On-site spray dryers include
best-in-class GEA Niro SD1, SD4 and SD7, the latter being the
largest CGMP unit of its kind for DPI in North America.Catalent
Pharma Solutions is hiring a Computer System Validation (CSV)/
Qualification Engineer is responsible for managing, developing, and
implementing the Computer System Validation program and equipment
qualification for the site to ensure compliance with local and
global regulatory agency requirements, internal company standards,
and current industry practices. Validation activities include
equipment, instrument, cleaning, computer and process validation.--
This is a full time, salaried role, The core hours are Monday -
Friday 8:00AM - 4:30PM Catalent is committed to a Patient First
culture through excellence in quality and--compliance, and to the
safety of every patient, consumer, and Catalent employee.--The
Role
- Performs and leads computer system validation projects related
to reviewing, authoring, and executing specifications and
validation documentation for process equipment/systems, laboratory
automated instruments/equipment, and systems according to the GAMP5
Validation Life Cycle.
- Generate and/or support validation deliverables including
validation project plans, system impact assessments, user
requirements, test strategies, risk assessments, data integrity
assessments, test protocols, and summary reports to address the
Validation lifecycle in line with corporate guidelines procedures,
CGMP, and ISPE GAMP guidelines and regulations.
- Identify specific tests and requirements to be met in the
IQ/OQ/PQ that address system requirements.
- Ensure all work is in line with the site Master Validation
Plan, regulations, procedures, and practices.
- Ensure that the site Validation Master Plan remains current and
aligned with corporate policies.
- Perform Data Integrity Assessment (DIA) and System Impact
Assessment (SIA) for Computerized Systems.
- Lead and conduct validation activities in compliance with US
and EU regulations (regulations for all countries where have
business) procedures and EHS requirements.
- Review and execute computer system validation protocols to
ensure compliance and adherence with corporate guidelines
procedures, CGMP, and ISPE GAMP guidelines and regulations.
- Write and review risks assessments and applicable test scripts
according to GMP and 21 CFR Part 11 compliance guidelines and the
site Validation Master Plan.
- Prepare validation summary reports for executed protocols.
- Communicate computer system validation approaches and
requirements during audits.
- Generate and maintain computer system validation procedures in
line with corporate guidelines procedures, CGMP, Corporate
policies/standards, and ISPE GAMP guideline.
- All other duties as assignedThe Candidate
- Bachelor's degree in Computer Science, or other Science,
Technology, Engineering, Mathematics related field;
- Requires minimum of 5 years in a CGMP-related industry with at
least three (3) to four (4) years of Computer System Validation
experience working with cGMP pharmaceutical /nutraceutical
regulated industries and 21 CFR Part 11 compliance (world CSV
regulations);
- Familiarity with computer infrastructure, servers,
workstations, Operating Systems, and database management
systems;
- Familiarity with computerized pharmaceutical GMP systems such
as LIMS, CDS, BMS, JDE, SAP, Analytical Instrumentation,
Manufacturing and Packaging systems, Quality Management Systems,
and their associated vendors;
- Must be trained in GMP Quality systems such as Change Control,
CAPA and Deviation;
- Experience with Electronic Document Management and Learning
Management Systems preferred (EDMS);
- Knowledge with Calibration Activities and Preventative
Maintenance;
- Individual may be required to sit, stand, walk regularly and
occasionally lift 0-15 pounds;Why you should join Catalent:
- Defined career path and annual performance review and feedback
process--
- Diverse, inclusive culture--
- Positive working environment focusing on continually improving
processes to remain innovative
- Potential for career growth on an expanding team within an
organization dedicated to preserving and bettering lives--
- 152 Hours + 8 paid holidays
- Several Employee Resource Groups focusing on D&I
- Dynamic, fast-paced work environment
- Community engagement and green initiatives--
- Generous 401K match--
- Company match on donations to organizations
- Medical, dental and vision benefits effective day one of
employment--
- Tuition Reimbursement--- Let us help you finish your degree or
start a new degree!
- WellHub program to promote overall physical wellness--
- Perkspot - offers exclusive or private discounts from
approximately 900+ merchants in a wide array of categoriesCatalent
offers rewarding opportunities to further your career!-- Join the
global drug development and delivery leader and help us bring over
7,000 life-saving and life-enhancing products to patients around
the world. Catalent is an exciting and growing international
company where employees work directly with pharma, biopharma and
consumer health companies of all sizes to advance new medicines
from early development to clinical trials and to the market.
Catalent produces more than 70 billion doses per year, and each one
will be used by someone who is counting on us. Join us in making a
difference.--personal initiative. dynamic pace. meaningful
work.Visit to explore career opportunities.Catalent is an Equal
Opportunity Employer, including disability and veterans.If you
require reasonable accommodation for any part of the application or
hiring process due to a disability, you may submit your request by
sending an email, and confirming your request for an accommodation
and include the job number, title and location to . This option is
reserved for individuals who require accommodation due to a
disability. Information received will be processed by a U.S.
Catalent employee and then routed to a local recruiter who will
provide assistance to ensure appropriate consideration in the
application or hiring process.--------Notice to Agency and Search
Firm Representatives: Catalent Pharma Solutions (Catalent) is not
accepting unsolicited resumes from agencies and/or search firms for
this job posting. Resumes submitted to any Catalent employee by a
third party agency and/or search firm without a valid written &
signed search agreement, will become the sole property of Catalent.
No fee will be paid if a candidate is hired for this position as a
result of an unsolicited agency or search firm referral. Thank
you.Important Security Notice to U.S. Job Seekers:Catalent NEVER
asks candidates to provide any type of payment, bank details,
photocopies of identification, social security number or other
highly sensitive personal information during the offer process, and
we NEVER do so via email or social media. If you receive any such
request, DO NOT respond- it is a fraudulent request. Please forward
such requests to spam@catalent.com for us to investigate with local
authorities.California Job Seekers can find our California Job
Applicant Notice .
Keywords: Disability Solutions, West Hartford , Computer Systems Validation and Qualification Engineer, IT / Software / Systems , Chelsea, Connecticut
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