Validation Engineer

Position Summary:

We are looking for a Validation Engineer for an immediate start. In this position you will plan, write, implement, and review CSV documents related to the onboarding and validation of new and existing QC Systems. This is a very dynamic and fast-paced environment located in Baltimore, MD. The candidate is expected to multi-task, communicate effectively, and possess a strong work ethic. The position will be contract driven and compensation will be hourly-based and very competitive.

Responsibilities

• Ensure vendor qualification documentation are pre-approved by required stakeholders prior to execution
• Facilitate vendor qualification of instrumentation
• Draft qualification documentation for equipment and analytical instruments including System Impact Assessments (SIA), GxP assessments, System Risk Assessments (SRA), User Requirement Specifications (URS), Installation and Operational and Performance Qualification Documentation (IOQ or IOPQ Trace Matrix (TM), and/or Summary Reports (SR)
• Draft IQ and OQ Test Scripts
• Provide support and/or execute IQ/OQ/PQ Protocols
• Translate system requirement specifications into executable validation protocols
• Write reports summarizing system validation
• Attend update meetings and provide status updates of current projects
• Work with cross functional teams, system owners and stakeholders to review and approve documentation
• Work with Information technology (IT) team to secure workstations, provide access to vendors, add software systems to domain and administration support
• Will need to engage with team members across company networks which span multiple locations within the U.S.
• Will work collaboratively with other colleagues and functions within the Client network

Education and Experience

• Bachelor's Degree in Chemistry, Biology, Microbiology or a related field preferred
• QC, cGMP, GAMP 5, Biotechnology, and/or Pharmaceutical experience is preferred
• Computer Systems Validation (CSV) experience required

Functional Requirements

• Knowledge and understanding of GAMP 5, 21 CFR Part 11, Computer System Validation and Quality Management System
• Working knowledge of Microsoft Office Applications
• Strong understanding of good manufacturing practices and/or good laboratory practices
• Working Knowledge of 21 CFR Part 11 compliance in a GMP/GLP regulated industry, Data Integrity, GDP and adherence to ALCOA principles

ANSA Compliance Non-Negotiables

• Need to be self-motivated and capable of working in a fast-paced environment
• Candidate must be dependable, reliable, and professional
• Must be able to demonstrate leadership in a dynamic organization
• Work with communication and project management skills to assist with project completion
• Must demonstrate honesty and integrity
• Comply with the company code of conduct and policies and regulatory standards

Company

ANSA Compliance is a compliance service, project management, and staffing provider that specializes in serving the pharmaceutical, biotechnology, and medical device industries. With over 20 years of combined experience in the compliance sector, the ANSA team can support clients throughout any stage in the development lifecycle.

ANSA Compliance pledges to create and maintain a workplace where all employees have the chance to participate and contribute to the success of the business. Employees at ANSA Compliance are valued and appreciated for the skills, experience, and unique perspective that they bring.

Job Types: Full-time, Contract

Pay: $40.00 - $80.00 per hour

Experience level:

• 2 years

Schedule:

• Monday to Friday

Work setting:

• In-person

Ability to commute/relocate:

• Baltimore, MD: Reliably commute or planning to relocate before starting work (Preferred)

Experience:

• CSV: 1 year (Preferred)

Willingness to travel:

• 25% (Preferred)

Work Location: One location