Polaris Pharmaceuticals Inc.

Validation Engineer II, Cleaning Validation

VACAVILLE, CAPosted 23 days ago

Job summary

  • Job post source

    This job is directly from Polaris Pharmaceuticals Inc.

  • Job overview

    The Validation Engineer II, Cleaning Validation, is responsible for commissioning, qualification, and validation of biopharmaceutical equipment and facilities to ensure compliance with cGMP guidelines, focusing on cleaning validation.

  • Responsibilities and impact

    The role involves developing and executing cleaning validation strategies, authoring and reviewing validation protocols, maintaining schedules, performing various qualification protocols, interpreting data, conducting risk assessments, and ensuring regulatory compliance.

  • Compensation and benefits

    The salary range is $120K to $140K per year. Additional benefits are not specified in the description.

  • Experience and skills

    Candidates should have a B.S./B.A., M.S., or PhD in Engineering or Science with 1-9 years of relevant cGMP validation experience, strong documentation, communication, and organizational skills, and experience in cleanroom environments.

  • Work environment and culture

    The company values respect, passion, teamwork, integrity, honesty, commitment, and collaboration, emphasizing a regulated cGMP work environment.

  • Company information

    Polaris Pharmaceuticals Inc. is a biopharmaceutical company focused on validation and manufacturing processes in compliance with regulatory standards.

  • Team overview

    The candidate will join the Validation department under the supervision of the Associate Director of Validation, collaborating with cross-departmental teams.

  • Unique job features

    The job requires working in cleanrooms with gowning protocols and involves interaction with multiple manufacturing processes including Upstream, Downstream, and Aseptic Fill Suite.

Company overview

Polaris Pharmaceuticals Inc. is a biopharmaceutical company focused on developing and commercializing innovative cancer therapies. They generate revenue through the research, development, and sale of proprietary drugs designed to target and treat various forms of cancer. Founded in 2006, the company has made significant strides in oncology, with several products in different stages of clinical trials. Polaris is known for its commitment to advancing cancer treatment and improving patient outcomes through cutting-edge science and technology.

How to land this job

  • Tailor your resume to emphasize your experience in cleaning validation, equipment and facilities qualification, and adherence to cGMP guidelines, as these are central to the Validation Engineer II role at Polaris Pharmaceuticals Inc.

  • Highlight your skills in authoring, reviewing, and executing validation protocols such as FAT, SAT, IQ, OQ, and PQ, along with your ability to manage validation schedules and coordinate cross-departmentally.

  • Apply through multiple channels including the Polaris Pharmaceuticals corporate career site and LinkedIn where the position is likely posted, increasing your chances of being noticed.

  • Connect with current Validation team members or those in the manufacturing and quality departments on LinkedIn; use ice breakers like asking about their experience with cleaning validation at Polaris or commenting on recent company projects related to cGMP compliance.

  • Optimize your resume for ATS by incorporating keywords from the job description such as 'cleaning validation,' 'cGMP,' 'qualification protocols,' 'risk assessment,' and 'cleanroom experience' to ensure your resume passes initial automated screenings.

  • Consider using Jennie Johnson's Power Apply feature to automate tailored applications, identify all relevant job postings, and find LinkedIn contacts to network with, allowing you to focus your energy on interview preparation and skill enhancement.

Jennie Johnson works for you!

Here’s what we do to make sure you’re successful:

  • Targeted Resume Revamp:

    We expertly craft your resume to navigate Applicant Tracking Systems (ATS) and showcase your qualifications, making you stand out as a top-tier candidate.

  • Job Description Dissection:

    Unpack the job posting with expert analysis, ensuring your application hits every key requirement.

  • Bespoke Cover Letter:

    Capture the attention of hiring managers with a personalized cover letter that highlights how your skills align perfectly with the job's needs.

  • Interview Mastery:

    Prepare for interviews like a pro with likely questions, strategic answers, and insightful questions for you to ask, setting you apart as an informed candidate.

  • Direct Application Insights:

    Receive tailored advice on the best places to apply, ensuring your applications are seen by the right employers.

  • Skills and Gaps Assessment:

    Identify and close critical skills gaps to position yourself as the best-fit candidate for your ideal job.

  • Personalized Email Pitch:

    Make a memorable first impression with an email template crafted to engage potential employers and initiate meaningful conversations.

  • In-depth Research Guide:

    Leverage comprehensive research tools to gather effective insights on companies, industry trends, and role-specific challenges.

  • Detailed Company Analysis:

    Gain in-depth understanding of your prospective employer, giving you the edge in applications and interviews.

  • Strategic Candidate Overview:

    Understand your unique value and why companies would want to interview you, highlighting your background and positioning.