3 Staff Validation Engineer Jobs in Middletown, VA
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Staff Validation Engineer
$106k-122k (estimate)
Intern | Business Services
2 Months Ago
LanceSoft Inc is Hiring a Staff Validation Engineer Near Middletown, VA
Shift: 1st shift, Mon-Friday
Duration: 12 Months, Temp to Perm Opportunity
Pay range: $60.00- $60.00 Hourly
100% Onsite jobThe Staff Validation Engineer will oversee development and execution of project validation master plans and identify approaches based on risk. The Validation Engineer will also oversee other Validation Engineers and consultants as well as develop, scale up, optimize, evaluate, and calibrate equipment, systems, and write procedures and protocols. The Validation Engineer will also manage timelines, metrics, scope, and site reporting requirements. This position will demonstrate complete understanding of validation related activities to independently manage the strategy around increasingly complex projects.
Key Responsibilities
This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, training, and apprenticeship. LanceSoft makes hiring decisions based solely on qualifications, merit, and business needs at the time.
Duration: 12 Months, Temp to Perm Opportunity
Pay range: $60.00- $60.00 Hourly
100% Onsite jobThe Staff Validation Engineer will oversee development and execution of project validation master plans and identify approaches based on risk. The Validation Engineer will also oversee other Validation Engineers and consultants as well as develop, scale up, optimize, evaluate, and calibrate equipment, systems, and write procedures and protocols. The Validation Engineer will also manage timelines, metrics, scope, and site reporting requirements. This position will demonstrate complete understanding of validation related activities to independently manage the strategy around increasingly complex projects.
Key Responsibilities
- Independently manages other validation engineers and/or consultants, tracks overall project validation master plan progress and provides dashboard updates to senior management
- Consults with management, assesses customer requirements, and studies product characteristics to select validation objectives and standards
- Develops validation strategies and approaches consistent with all applicable site guidance documents and writes protocols for validation or performance testing of manufacturing equipment, processes, or systems
- Applies current validation best practices and knowledge of risk-based validation approaches across a wide range of manufacturing sub-assembly and assembly processes.
- Executes qualifications and validations as needed
- Analyzes data from validation tests to determine whether systems and processes meet required criteria and specifications
- Collaborates and coordinates with appropriate departments and staff regarding the scheduling or implementation of validation testing
- Identifies root causes of production problems associated with validation
- Identifies nonconformities of product or process standard and offers recommendations for resolving deviations
- Develops and maintains databases for tracking test results, validation activities, or validated systems
- Develops, maintains, or reviews validation and compliance documentation including schematics, protocols, and engineering change notices
- Modifies testing methods or revisits test objectives and standards to resolve testing problems.
- Calibrates equipment to ensure accurate measurements.
- Performs other related duties as assigned
- Identifies scale up and cost savings opportunities and directly plans and supports scale up, optimization, and development of new manufacturing processes
- Bachelor’s degree in related field required
- 04-08 years of experience within the Medical Device or Pharmaceutical Industry supporting the manufacture of Regulated Products
- Knowledge of validation in a FDA Regulated Environment.
- Knowledge and understanding of
- Quality standards (e.g., 21 CFR Part 820, ISO 13485)
- Quality tools (e.g. FMEA, Risk Analysis, Root Cause Analysis)
- Computer Systems (e.g. TrackWise, MasterControl, AGILE, SAP)
- Proficient in:
- Computer applications and current software (Microsoft Excel, Outlook, Word, Access, Project) and technical writing
- Experience supporting a project team responsible for validation preferred
- Experience supporting mixing and cleaning validations for formulation vessels and fill lines preferred.
- Excellent verbal and written communication skills required
- Excellent interpersonal skills required
- Thorough understanding of industry standards and regulatory guidelines
- Thorough understanding of applicable mathematics and scientific practices including statistical sampling plans and statistical and data analysis
- Thorough understanding of related equipment and the ability to perform equipment modifications
- Proficient with Microsoft Office Suite or related software
- Four options of medical Insurance
- Dental and Vision Insurance
- 401k Contributions
- Critical Illness Insurance
- Voluntary Permanent Life Insurance
- Accident Insurance
- Other Employee Perks
This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, training, and apprenticeship. LanceSoft makes hiring decisions based solely on qualifications, merit, and business needs at the time.
Job Summary
JOB TYPE
Intern
INDUSTRY
Business Services
SALARY
$106k-122k (estimate)
POST DATE
07/22/2024
EXPIRATION DATE
10/12/2024
WEBSITE
lancesoft.com
HEADQUARTERS
HERNDON, VA
SIZE
500 - 1,000
FOUNDED
2000
TYPE
Private
CEO
DIVYA GANDHI
REVENUE
$200M - $500M
INDUSTRY
Business Services
Related Companies
About LanceSoft Inc
LanceSoft is a provider of application development, management outsourcing and data-warehousing services to the aerospace and automotive sectors.
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