200+ applicants

Company

Original Job Post

Sequoia Biotech Consulting · 2 days ago

Validation Engineer

Raleigh, NC

Full-time

Onsite

Entry, Mid Level

$69K/yr - $213K/yr

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Responsibilities

Develop validation master plans and protocols for equipment, processes, and systems used in pharmaceutical manufacturing.

Collaborate with cross-functional teams to ensure validation activities align with project timelines and regulatory requirements.

Execute validation protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), for manufacturing equipment and processes.

Conduct risk assessments and validation studies to identify potential issues and implement corrective and preventive actions.

Maintain accurate and detailed validation documentation, ensuring compliance with regulatory standards and internal procedures.

Prepare validation reports summarizing findings, conclusions, and recommendations for stakeholders and regulatory submissions.

Assess the impact of proposed changes to equipment, processes, or systems on validation status.

Manage change control processes, ensuring that changes are properly evaluated, documented, and validated to maintain compliance.

Collaborate with engineering, quality, and production teams to implement validation requirements for new equipment and processes.

Provide training and guidance to staff on validation procedures, documentation practices, and regulatory compliance requirements.

Stay updated on industry trends, regulatory guidelines, and best practices related to validation activities.

Identify opportunities for process improvements and implement best practices to enhance validation efficiency and effectiveness.

Qualification

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CommissioningQualificationValidationHVACWater-for-InjectionAutoclavesGlasswashersCIPBioreactorsChromatography SystemsFiltration SystemsProject ManagementProblem-SolvingAttention to DetailEffective CommunicationTeamwork

Required

Bachelor's degree in Chemical Engineering, Mechanical Engineering, or related field.

Experience in commissioning, qualification, and validation in a regulated industry

Hands-on startup, commissioning, and qualification experience with one or more of the following systems: HVAC, Water-for-Injection, Autoclaves, Glasswashers, CIP, Bioreactors, Chromatography systems, Filtration systems

Strong project management skills, including the ability to manage multiple projects simultaneously.

Excellent problem-solving abilities and attention to detail.

Effective communication skills and ability to work collaboratively in a team-oriented environment.

Benefits

Medical

Dental

Vision coverage

401K

Company paid life-insurance

Company

Sequoia Biotech Consulting

Sequoia Biotech Consulting is a leading life sciences consulting firm that provides a wealth of tenured expertise necessary for quickly and efficiently scaling life science organizations to deliver high-quality therapeutics, diagnostics, and medical devices.

Founded in 2016

Encinitas, California, USA

201-500 employees

https://sequoiabiotech.com

H1B Sponsorship

Sequoia Biotech Consulting has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Trends of Total Sponsorships

2020 (1)