Sr. Validation Engineer/Sr. Validation Engineer I

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 team! We are looking to add a validation engineer with computer system validation or equipment qualification experience to our Quality Control support team. The HTO Quality Control team is investing in our ability to bring current and new analytical technologies to Lab quickly and efficiently in a standardized and compliant manner. As a 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.

Job Functions:

• 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.

• You will define, establish, standardize, and complete and/or improve practices for maintaining the validated state of analytical, microbial and bioassay equipment 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 (e.g.: Out of Specifications, Out of Expectations, Over Action Limits, local and global process deviations) using established Root Cause Analysis tools and generating data-based impact assessments related to supported methods within established timelines.

• You will collaborate with key partners to identify and complete Corrective and Preventive Action Plans related to supported methods, completing assigned actions through self or others with tact and effective communication skills.

• 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.

Who You Are:

Sr. Validation Engineer I

• You hold a Bachelor's of Science degree with 8-11 years of dynamic experience in the pharmaceutical or scientific industry or 6-8 years of experience with a graduate degree. 3 years of experience working in a cGMP or similarly regulated environment is required.

Sr. Validation Engineer

• You hold a Bachelor's of Science degree with 4-7 years of dynamic experience in the pharmaceutical or scientific industry or 2-4 years of experience with a Graduate degree. 3 years of experience working in a cGMP or similarly regulated environment is required.

For both roles:

• 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.

Work Environment/Physical Demands/Safety Considerations

• 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.

The expected salary range for the Validation Engineer I based on the primary location of Oregon is $67,700 to $125,700. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. 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.

The expected salary range for the Validation Engineer based on the primary location of Oregon is $96,700 to $179,700. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. 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.

Benefits

Relocation benefits are provided for this position.

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