Validation Engineer, Commercial Operations at Serán BioScience

Bend, Oregon, United States

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceutical, BiotechnologyIndustries

Requirements

Candidates should possess a Bachelor’s degree in a scientific discipline, such as Engineering, Biology, or Chemistry, and have at least five years of experience in pharmaceutical validation, with a strong understanding of cGMP regulations and FDA requirements. They must demonstrate thorough knowledge of processes and systems to be studied, as well as an understanding of all applicable regulations, guidelines, policies, procedures, and requirements. Effective communication skills are essential for collaborating with internal and external teams.

Responsibilities

The Validation Engineer will support Commercial Leadership in developing CQ and validation programs to support projects for new product introduction, tech transfer, and product/process optimization within the commercial manufacturing facility for non-sterile pharmaceutical products. They will lead cross-functional internal and external teams during the execution of CQ and validation projects, overseeing external commissioning of resources, maintaining CQ and validation programs in conformance with guidelines, policies, and requirements, and ensuring harmonization with clinical CQ programs. The role involves coordinating training, executing validation studies, working with teams to enhance quality and technical systems, managing project budgets, and performing other related duties as assigned.

Skills

cGMP

FDA

Commissioning

Qualification

Process Validation

Cleaning Validation

Computerized Systems Validation

Tech Transfer

Manufacturing Processes

Serán BioScience

Contract development and manufacturing for pharmaceuticals

About Serán BioScience

Serán BioScience specializes in providing drug development and manufacturing services as a Contract Development and Manufacturing Organization (CDMO). They offer a variety of services, including preformulation, formulation development, dosage form development, spray drying, and particle engineering. Their operations adhere to current Good Manufacturing Practice (cGMP) standards, ensuring high quality and safety in their products through rigorous analytical quality control. Serán BioScience serves a wide range of clients, from small biotech startups to large pharmaceutical companies, and is distinguished by its flexibility in tailoring services to meet specific client needs. The company's goal is to enhance the efficiency and effectiveness of drug development processes for their clients.

Bend, OregonHeadquarters

2016Year Founded

$194.5MTotal Funding

GROWTH_EQUITY_VCCompany Stage

Biotechnology, HealthcareIndustries

51-200Employees

Benefits

Paid Vacation

401(k) Retirement Plan

Health Insurance

Life Insurance

Disability Insurance

Mental Health Support

Pet Insurance

Risks

Emerging CDMOs in Asia offer lower-cost services, impacting Serán's market share.

Potential delays in new facility construction could affect expansion plans.

Global talent shortage may hinder recruitment for Serán's expansion.

Differentiation

Serán specializes in advanced drug formulation techniques, including spray drying and particle engineering.

The company offers cGMP manufacturing and analytical quality control services.

Serán's flexibility allows tailored services to meet specific client needs.

Upsides

Serán announced a $200 million strategic growth transaction for expansion.

The company plans to build a new commercial-scale manufacturing facility.

Increased demand for personalized medicine aligns with Serán's formulation expertise.

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