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

Open nowPosted 4 days ago

Process Engineer II

siegfried48 open roles

Pay
$115,000 – $130,000 a year
Where
Irvine, CA
Get the CV for this job

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

Your applicationOpen nowProcess Engineer IIsiegfried · Irvine, CA

  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 siegfried'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.

13.6% of postings close within 7 days. Measured by our own scanner across the market. siegfried postings stay open a median of 26 days.

Share of postings closed within
  1. 2.3%1 day
  2. 4.7%3 days
  3. 13.6%7 days
  4. 21.9%14 days
  5. 36.9%30 days
  6. 59.0%60 days
This job: posted 4 days ago

siegfried median: 26 days open

The posting

"Expect to grow", personally and professionally: At Siegfried, we offer exciting challenges and ample opportunities to showcase your talents. As a trusted and respected partner to the pharmaceutical industry, we uphold the highest standards in safety, quality and sustainability, while fostering a culture that empowers you to thrive. Join a rapidly expanding global company, where diverse perspectives and experiences come together in a collaborative environment. Here, you'll find a workplace that values both collective success and your individual contributions—offering long-term opportunities to grow and make an impact.

Your Role:

Scope and Purpose of the Position

The Process Engineer II within Manufacturing Science & Technology (MS&T) Department provides the site with knowledge and expertise required to support our diverse portfolio encompassing pharmaceutical process development, technology transfers, and commercial products. This individual will oversee implementation of new technologies by designing, planning, executing, and interpreting scientific reports or experiments to contribute to the overall success of MS&T organization. They will also play a key role in driving continuous process improvements and innovation for the Irvine manufacturing site. This client-facing position requires an advanced level of proficiency in late-stage process development or clinical and commercial manufacturing operations as well as excellent interpersonal skills.

Your Profile:

Responsibilities

  • Support technology transfers as a subject matter expert overseeing the transfer of processes and technologies from the client's process development to GMP manufacturing to support new product introduction.
  • Contribute to technical evaluation of new processes, technologies, methods, and/or materials and facilitate related innovation focusing on delivering customer needs and a GMP product.
  • Own the knowledge of pharmaceutical manufacturing process technologies used in the scale-up, scale-down, and design of experiments (DoE).

· Participate in the creation of manufacturing procedures and SOPs for new processes and products. Own and support process validation studies and the data /trend analysis. Responsible for the robustness and capability of the manufacturing processes developed using statistical analysis to create and monitor Critical Process Parameters (CPPs) and Critical Quality Attributes (CQAs).

  • Own deviations, CAPAs, and audit responses. Support on-the-floor troubleshooting and root-cause investigations.
  • Develop a collaborative culture with key partners (Global and Site) and customers, including Validation, Analytical Development.

· Develop potential clients' presentations and proposal generations including project evaluations and technical feasibility assessments.

  • Build scientific knowledge and increase technical know-how within and beyond the MSAT department. Provide technical training and mentorship to junior MS&T members and manufacturing operators.

Required Knowledge, Skill, and Abilities

  • Strong understanding and hands-on experience in GMP manufacturing or process development of parenteral products, including the quality attributes and manufacturing controls for pharmaceuticals or biologics.
  • Working knowledge of risk-based decision-making and stage-appropriate implementation strategies supporting clinical manufacturing, technology transfers, and commercial manufacturing.
  • Capable of working with global and cross-functional teams in dynamic and time-bound environments.

· Capable of building effective working relationships across departments (QA, Project Management, Business Development, and Manufacturing) to support the introduction of new processes and products.

  • Experience with root cause analysis and product quality impact assessments for deviations and investigations utilizing Lean and Six Sigma tools.
  • Capable of identifying issues, providing solutions, and forward thinking through solid problem solving.

· Able to effectively communicate with internal and external clients on matters concerning technical feasibility and GMP readiness.

  • Working knowledge of GMP production-related IT systems such as SAP and LIMS is desired.

Required Education and Experience

· Bachelor's Degree in Engineering or science-related field with six years of industry experience or Master's degree with four years of industry experience.

· Minimum three years of experience in Fill/Finish or Aseptic Process operations, preferably in clinical or commercial GMP manufacturing.

· Minimum three years of experience bringing pharmaceutical equipment, process, or methods from development to GMP operational readiness.

· Equivalent education or experience may substitute the stated requirements.

Target salary range is $115,000 - $130,000

Individual compensation packages are based on various factors unique to each candidate, including skill set, experience, qualifications, and other job-related reasons.

Your Benefits:

Your Benefits:

  • Medical, Dental, Vision
  • Flexible Spending & HSA Options
  • Life Insurance, Short- & Long-Term Disability
  • Pet Insurance
  • Generous PTO, Sick & Holiday Time Off
  • 401K

Founded in 1873 in Zofingen, Switzerland, Siegfried has grown into a global network of 16 sites across three continents. With a team of more than 4,200 highly skilled professionals, we take the innovations of our pharmaceutical customers to industrial scale and manufacture safe drugs for patients worldwide. As a fully integrated CDMO, Siegfried is one of the few organizations today that can carry out the development and manufacturing of APIs and finished dosage forms under one roof. This unique combination of know-how and experience makes us the most trusted partner in the pharmaceutical industry.

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 siegfried'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 siegfried'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

    siegfried'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.