Principal Validation Engineer
Principal Validation Engineer
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$ 83230 - 153400
1 Vacancy
Job Description
At Roche you can show up as yourself embraced for the unique qualities you bring. Our culture encourages personal expression open dialogue and genuine connections where you are valued accepted and respected for who you are allowing you to thrive both personally and professionally. This is how we aim to prevent stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche where every voice matters.
The Position
A healthier future. Its what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. Thats what makes us Roche.
As a Principal Validation Engineer you will lead high-impact validation projects across equipment facilities and utilities within a cutting-edge regulated environment. In this role youll write and execute IQ/OQ/PQ protocols guide complex cross-functional initiatives and apply Lean and Six Sigma principles to drive continuous improvement. Youll work closely with cross functional stakeholders while also mentoring junior team members and helping shape validation strategy from concept through execution.
The Opportunity
Writes and executes Equipment Facility and Utilities Installation/Operational/Performance Qualifications (IQ/OQ/PQ) protocols on a variety of facility and manufacturing process equipment and analytical testing equipment in a full Biotech upstream/downstream manufacturing plant. Qualification includes conception of qualification assessments (basic to complex) protocol strategy authoring protocols execution and final report writing.
Leads and provides qualification and validation support to complex and/or multinational projects in his/her assigned area. Participates and leads project planning qualification/validation scheduling process updates and experimental design. Assumes responsibility for timely completion of projects or assigned work ensuring activities are consistent with project critical path and responding appropriately to changing priorities.
Deep technical knowledge of qualification of equipment facilities and utilities. Conceives plans and conducts independent qualification/validation work or project work from inception through product launch and field support defining schedules and applying qualification or validation strategy that is robust and agile to complete projects.
Apply Program Management tools to define and monitor project timelines ensuring timely achievement of overall project goals and establishing priorities that are in line with the overall business needs.
Utilizes Continuous improvement/Lean/Six Sigma manufacturing concepts to improve processes.
Provides technical advice/guidance to junior scientific staff and leads project teams to solve business problems of moderate size risk and complexity and serves as an overall role model.
Serves as an expert resource to other departments (e.g. Manufacturing/Operations Development Quality Regulatory Affairs and Technical Services) provides timely response and follow-ups.
Who you are
You have a Bachelors degree in an Engineering Engineering Technology or Life Science discipline. A Masters degree in one of these fields is preferred.
You have 6 years of relevant industry experience in Equipment and/or Facility Validation. 7 years of experience is preferred.We will consider an equivalent combination of education and experience.
A Masters degree in Engineering may qualify with 6 or more years of experience in complex mechanical or chemical systems development and validation.
Knowledge Skills and Abilities
Solid understanding in the manufacture of assays reagents and instruments as well as Verification and Validation principles practices and tools used in that transfer.
Proven ability to work on complex problems with analysis of situations or data towards successful outcomes.
Demonstrated ability to apply Lean and 6 Sigma methodology in all that you do and a passion to drive It throughout the organization
Proven ability to contribute and interact productively and collaboratively with project teams.
Excellent verbal communication skills required. Excellent interpersonal skills required to interact with stakeholders such as system owners quality assurance and auditors.
Excellent technical writing skills required. Studies protocols reports deviations and non-conformances must be written in a clear structured manner directed to reviewers in an FDA regulated environment.
The candidate must be a self-starter with the ability to work with minimal supervision in a fast paced environment. The candidate must have the ability to prioritize and manage multiple projects and priorities. The candidate must be a team player willing to help others and cross train them as necessary.
Permits/ Permits/Licenses and Certifications
ASQC Certified Quality Engineer is a plus
ISPE Certified Pharmaceutical Industry Professional (CPIP) is a plus.
Relocation benefits are available for this posting
The expected salary range for this position based on the primary location of California is $83230 and $153400. 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.
Who we are
GenMark is now a proud member of the Roche Group more than 100000 people across 100 countries are pushing back the frontiers of healthcare. As a global leader in healthcare Roche Diagnostics offers a broad portfolio of products tools and services that help in the prevention diagnosis and management of diseases like HPV HIV hepatitis and diabetes as well as other medical conditions such as fertility and blood coagulation. With the addition of GenMark to the Roche Group syndromic infectious disease diagnostics is now added to the long list of disease states and conditions that the Roche Group addresses. GenMarks ePlex true sample-to-answer system offers unique solutions to address the most significant challenges facing clinical laboratories while supporting hospital systems to deliver patient-centered value-based care. ePlex streamlines the diagnostic workflow from physician order entry to the final test report and is the true sample-to-answer solution designed to improve patient care reduce costs and increase lab efficiency. GenMark is headquartered in Carlsbad California.
GenMark 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 companys 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.
Required Experience:
Staff IC
Employment Type
Full-Time
