Skip to content
CV Rocket
Get started
How it worksThe enginePricingBlogContactSign in

Open nowPosted 7 days ago

Process Validation Engineer

roche127 open roles

Where
Oceanside
Get the CV for this job

From $25 per CV, paid once. No subscription.

Your applicationOpen nowProcess Validation Engineerroche · Oceanside

  1. YouYes, apply to this one.

  2. CV RocketCV written for this posting.

  3. 25 readersRecruiter, hiring manager, skeptic. Round after round.

  4. CV RocketApplied on roche's own form.

The reply lands in your private mailbox

3×more interviews than doing it yourself with ChatGPT.

The clock on this job

Early applications get read.

8.0% of postings close within 7 days. Measured by our own scanner across the market. roche postings stay open a median of 3 days.

Share of postings closed within
  1. 1.6%1 day
  2. 3.6%3 days
  3. 8.0%7 days
  4. 15.0%14 days
  5. 34.2%30 days
This job: posted 7 days ago

roche median: 3 days open

The posting

Oceanside Operations (OCN) is a drug substance manufacturing organization dedicated to the reliable production of Roche’s commercial portfolio and pipeline products. Every year, OCN delivers millions of units of life-saving medicines to patients around the globe by leveraging its two integrated value streams: Stainless Steel and Single-Use production systems.

As a Process Validation Engineer in our Manufacturing Sciences and Technology (MSAT) group, you will support cross-functional process validation strategies, lead regulatory documentation efforts, and ensure compliance across site-specific initiatives. This role serves as a structured professional growth pathway where you will gain hands-on exposure to core validation methodologies alongside senior engineers while driving continuous process improvements.

The Opportunity

  • Author, edit, and execute Process Validation (PV) protocols, execution reports, and regulatory deliverables (such as PPQ OneDoc, PAS, and IMA) in accordance with cGMP standards.
  • Perform rigorous compliance and data-integrity checks on draft validation documents to ensure summary findings and data tables strictly align with raw supporting data.
  • Collaborate with the PV Lead to maintain the master schedule and submission filings, actively tracking project milestones.
  • Assist with technical activities for product introductions, process transfers, and capacity expansion efforts.
  • Facilitate review and approval workflows across cross-functional teams (Quality, MSAT, Regulatory), keeping partners accountable to project timelines.
  • Utilize digital quality systems (Veeva, Smartsheet, AppSheet) to track metrics and streamline documentation workflows.
  • Support root-cause investigations for discrepancies, aiding in the design and implementation of corrective actions (CAPAs).
  • Partner with senior engineers to gain hands-on experience executing equipment qualifications and cleaning validation studies.

Who you are

  • You hold a Bachelor’s degree in Chemical Engineering, Bioengineering, Life Sciences, or a related discipline with 4–6 years of relevant industry experience; OR a Master’s degree with 2–4 years of experience.
  • You possess practical experience with process validation concepts, technical writing, regulatory submission support, and Quality Systems within a cGMP biopharmaceutical manufacturing environment.
  • You have a strong foundational understanding of biopharmaceutical unit operations and process engineering principles.
  • You bring exceptional attention to detail with demonstrated skill in technical formatting, compliance checks, and verifying raw source data.
  • You are a strong communicator and proactive problem-solver who thrives when collaborating with cross-functional and global network partners.

Preferred

  • Familiarity with electronic document management systems such as Veeva Quality Docs/RIM, eVAL, or Smartsheet.
  • Experience working comfortably within office and cGMP cleanroom environments requiring full gowning.

Work Environment & Physical Demands

  • Mix of office and cGMP cleanroom environments.
  • Must be able to remain on feet/walk for extended periods (up to 8–10 hours).
  • Lift up to 25lbs may be required.
  • May work in the clean room environment that requires full gowning (scrubs, coveralls, gloves, safety glasses, and steel-toe boots); no makeup or jewelry permitted in processing areas..
  • Clean room environments feature large mechanical equipment, piping, and pumps connecting to tanks serviced by high-pressure steam, water and air together this creates a loud environment.
  • Work with hazardous materials and chemicals.
  • Ability to sit, stand and move within working city for extended periods.

Relocation benefits are not available for this posting.

The expected salary range for this position based on the primary location of California is $80,500 - $149,500. 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

Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.

If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.

From $25, paid onceGet the CV for this job

What happens when you press

One press. We do the rest.

  1. A CV for this posting

    Written against roche's own wording, from every piece of relevant proof in your profile.

  2. 25 readers review it

    Recruiter, hiring manager, skeptic and more read every draft, round after round. You get the best round.

    The review screen in CV Rocket: how each CV was read, round by round.

  3. We apply on roche's form

    Our application engine gets through the hardest forms there are. Where a question needs you, AI suggests the best answer. Don't want us applying from our IP addresses? Use our Chrome extension: we apply straight from your own browser.

    An application in CV Rocket: every answer filled in on the employer's form.

  4. Every reply, sorted

    roche's answer lands in your private mailbox, and we classify it on arrival: interview, question, rejection.

    The CV Rocket inbox: each employer reply classified as an interview, an action or a rejection.

  5. Reply with AI

    AI helps you write the email, checks it and sends it. We show you whether the recruiter read it.

  6. The interview in your calendar

    Full integration with your calendar. The invitation goes straight in.

    An interview invitation in the CV Rocket inbox, added to the candidate's calendar.
Get the CV for this job

From $25 per CV, paid once. No subscription.

Why it works

3×

more interviews than doing it yourself with ChatGPT.

ChatGPT writes a CV and never learns what happened to it. We see every reply. For each CV we know:

  • How it was written, and how the review scored it
  • When we applied, and how long after the posting went up
  • Which posting, which company, which city
  • Who got the interview, and who heard nothing

That is how we know which CVs get called.

Get the CV for this job

From $25 per CV, paid once. No subscription.

The numbers game

More applications. More interviews.

Every application goes out with its own CV, written for that posting and paid once. Send enough of them and the law of large numbers finds you the job.

Get the CV for this job
By hand5–10
With CV Rocket100
applications a day

Nearby

Live postings like this one

Same employer first, then the same role elsewhere.

Before you press

Straight answers

Get the CV for this job

From $25 per CV, paid once. No subscription.

What if my background isn't good enough?

We make the most of the background you have. The CV uses every piece of relevant proof your profile holds, and one of the 25 readers reads your whole profile and flags what the CV left out.

Do you really apply for me?

Yes, on the employer's own form, the hardest ones included. Where a question needs you, you answer it right there and AI suggests the best answer. Don't want us applying from our IP addresses? Use our Chrome extension: we apply straight from your own browser.

Is it a subscription?

No. You pay once per CV, from $25. Every application goes out with its own CV, written for that posting.

One job. One CV.
Paid once.

Pick the posting you want. We write for it, apply for you and catch the reply.

Get the CV for this job

From $25 per CV, paid once. No subscription.