Staff Validation Engineer

Lancesoft

Greenville, NC

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JOB DETAILS

SALARY

$100

SKILLS

Best Practices, Biotech and Pharmaceutical, Communication Skills, Consulting, Cost Control, Customer/Client Research, Data Analysis, Data Quality, Database Administration, Database Programming, Industry Standards, Interpersonal Skills, Manufacturing, Manufacturing Assembly, Manufacturing Equipment, Manufacturing/Industrial Processes, Mathematics, Metrics, Microsoft Office, Network Connectivity, Performance Testing, Presentation/Verbal Skills, Problem Solving Skills, Procedure Development, Quality Assurance Methodology, Quality Engineering, Regulations, Reporting Dashboards, Risk, Root Cause Analysis, Schematics, Statistical Sampling, Statistics, Strategic Planning, System Validation, Testing, Time Management, Validation Documentation, Validation Plan, Validation Testing, Writing Skills

LOCATION

Greenville, NC

POSTED

29 days ago

Shift: Monday-Friday 8-5
Pay Range: $90.00 - $100.00 Hourly
Duration: 12 Months
100% on site.

Position Summary:

The Staff Validation Engineer will oversee development and execution of 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 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
•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
Minimum Requirements/Qualifications:
•Bachelor’s degree in related field required
•11-15 years of experience in biotech manufacturing, quality, engineering, or validation required
Personal attributes:
•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

Employee Benefits:
At LanceSoft, full time regular employees who work a minimum of 30 hours a week or more are entitled to the following benefits:

Four options of medical Insurance
Dental and Vision Insurance
401k Contributions
Critical Illness Insurance
Voluntary Permanent Life Insurance
Accident Insurance
Other Employee Perks

About LanceSoft
LanceSoft is rated as one of the largest staffing firms in the US by SIA. Our mission is to establish global cross-culture human connections that further the careers of our employees and strengthen the businesses of our clients. We are driven to use the power of our global network to connect businesses with the right people, and people with the right businesses without bias. We provide Global Workforce Solutions with a human touch.

About the Company

Lancesoft

We are a $125 Million, NMSDC-certified Minority & Woman owned Workforce Solutions Company headquartered in the DC metro area with presence across US with global presence - Canada, Mexico, India, UK, Malaysia, Indonasia, Hongkong, Singapore, UAE. We are specialized in providing Workforce Solutions, SOW project delivery, Engineering Solutions, Creative Services. We currently support 100+ Fortune companies globally and across multiple industry segments. We are currently supporting several massive programs across industry segment nationally/globally (Intel, Ally, AMD, QUALCOMM, Morgan Stanley, Kraft/ Mondelez, MNP, Amdocs, Dell, SanDisk, Medtronic, Becton Dickinson, GE, Lockheed Martin, UTC, L-3 Communications, Caterpillar, BMW, Mercedes Benz, National Grid, Dominion, Energy Future Holdings, PSEG, 3M, Fidelity, Aetna, Humana, Johnson & Johnson, Pfizer, Merck etc).

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender, identity, national origin, disability, or protected veteran status.

COMPANY SIZE

2,000 to 2,499 employees

INDUSTRY

Staffing/Employment Agencies

FOUNDED

2000

WEBSITE

http://www.lancesoft.com/

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