Validation Engineer/Senior Validation Engineer, Quality Control

Genentech • Hillsboro, OR

12d • Onsite

About The Position

Hillsboro Technical Operations (HTO) is a drug product & finished goods manufacturing organization responsible for the reliable delivery of Roche’s commercial portfolio & pipeline products. The Operations organization at HTO is divided into three value streams, which combine to produce millions of units of life-saving medicine every year to patients around the world. The Opportunity: If you want to contribute to a fast paced operational team and you have an innate understanding of how equipment operates; then consider joining our Quality Control (QC) team! We are looking to add a QC Validation Engineer with computer system validation or equipment qualification experience to our Quality Control Support team. The site is investing in our ability to bring current and new analytical technologies to the QC labs quickly and efficiently in a standardized and compliant manner. As a QC Validation Engineer/Senior Validation Engineer, you will qualify various types of equipment / software that supports routine operations and introduction of new product lines at HTO. This position plays a meaningful role in establishing the validation history and maintaining the validated state of various equipment (e.g. plate readers, chromatographic equipment, liquid handling equipment, microbial detection systems, general laboratory equipment) used to test our drug products or maintain our aseptic fill/finish manufacturing facility. This role serves as a technical authority and is encouraged to solve equipment functionality, sustain the qualified state of analytical equipment, and share their knowledge with junior associates to increase the overall technical capability of the Quality Control organization. You will author, review and complete equipment qualification / computer system qualification protocols and generate equipment lifecycle documents (i.e. User Requirements Specifications, Data Integrity Assessments, Test Protocols, Operational and Administration Procedures, etc.) using Roche’s electronic validation system (ValGenesis) You will participate on analytical transfer teams with focus on equipment qualification. Facilitate / complete equipment gap assessments, contribute to comprehensive transfer plans, complete transfer activities related to equipment qualification in collaboration with QC Operations, Quality Validation and other Analytical Specialists from the donating and receiving sites. You will define, establish, standardize, and complete and/or improve practices for maintaining the validated state of QC equipment (analytical, microbial and bioassay) throughout its lifecycle through periodic reviews, monitoring, and re-qualification. You will serve as a site representative on network-wide validation teams formed to discuss emerging issues through resolution, and improve and standardize qualification of platform equipment. The information discussed at these teams are routinely submitted via a sponsor to decision making bodies within the relevant/impacted functional areas including HTO. As a representative, you will be the voice for HTO and are accountable for ensuring information / decisions are disseminated to and from these teams. You will participate in Quality Control investigations related to QC equipment issues and completing data driven impact assessments and actions. You will collaborate with key partners to identify and complete Corrective and Preventive Action actions. You will author, review, and/or approve various business process & compliance related documents such as, standard operating procedures, work instructions, monitoring protocols, monitoring reports, gap assessments, and risk assessments related to the supported methods.

Requirements

• You hold a Bachelor’s of Science degree with 1-3 years (Validation Engineer level) or 4-7 years (Senior Validation Engineer level) of dynamic experience in the pharmaceutical or scientific industry.
• You have significant experience working in a cGMP or similarly regulated environment
• You possess a deep understanding of equipment and/or computer system validation practices, regulations, and industry guidelines and consistently apply this understanding when performing your tasks.
• You are a strong problem-solver and have the proven ability to solve and resolve analytical instrument issues.
• You have the judgment / discretion to advance matters of significance, ensuring efficient testing operations and regulatory compliance.
• You possess outstanding social skills and strong written and verbal communication skills. You use these skills to build effective multi-functional teams and commit to timely informed decisions and completion of simple to moderate actions from others.
• You have a passion and ability for mentoring and encouraging others and are able to build/ maintain effective multi-functional teams without direct management responsibilities .
• You will be working on site in a flexible open space work environment with random visits to a QC laboratory environment that requires laboratory gowning (lab coat, goggles, gloves)
• You will work on/interact with analytical instruments and computerized systems/screens for long periods of time (6-8 hours)
• You may be required to lift up to 25lbs
• You may have to work with hazardous materials and chemicals.

Responsibilities

• Author, review and complete equipment qualification / computer system qualification protocols and generate equipment lifecycle documents (i.e. User Requirements Specifications, Data Integrity Assessments, Test Protocols, Operational and Administration Procedures, etc.) using Roche’s electronic validation system (ValGenesis)
• Participate on analytical transfer teams with focus on equipment qualification.
• Facilitate / complete equipment gap assessments, contribute to comprehensive transfer plans, complete transfer activities related to equipment qualification in collaboration with QC Operations, Quality Validation and other Analytical Specialists from the donating and receiving sites.
• Define, establish, standardize, and complete and/or improve practices for maintaining the validated state of QC equipment (analytical, microbial and bioassay) throughout its lifecycle through periodic reviews, monitoring, and re-qualification.
• Serve as a site representative on network-wide validation teams formed to discuss emerging issues through resolution, and improve and standardize qualification of platform equipment.
• Participate in Quality Control investigations related to QC equipment issues and completing data driven impact assessments and actions.
• Collaborate with key partners to identify and complete Corrective and Preventive Action actions.
• Author, review, and/or approve various business process & compliance related documents such as, standard operating procedures, work instructions, monitoring protocols, monitoring reports, gap assessments, and risk assessments related to the supported methods.

Benefits

• A discretionary annual bonus may be available based on individual and Company performance.
• This position also qualifies for the benefits detailed at the link provided below.
• Relocation benefits are available for this position.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Number of Employees: 5,001-10,000 employees