Software Validation Manager - 5647BR | GenomeWeb

Software Validation Manager - 5647BR

Organization
Illumina, Inc.
Job Location
San Diego, CA 92122
Salary
Open
Job Description

All About Us

Do you want to make a difference? Illumina’s mission is to improve human health by unlocking the power of the genome. If that inspires you, let’s talk. We’ve built a culture fueled by innovation, collaboration and openness, and established ourselves as the global leader in DNA sequencing and array-based technologies. Our people and our technology change lives by driving advancements in life sciences, oncology, reproductive health, agriculture and other emerging markets. We are deeply passionate about what we do, because we know that our work has the power to improve lives.

We’re an established company with a track record of phenomenal growth. Our revenue grew from $10 million in 2002 to approximately $2.2 billion in 2015. Our growth isn’t just revenue, we’ve been hiring the best and the brightest. Perhaps that’s why MIT has ranked Illumina near the top of its World’s Smartest Companies list three years running, including #1 in 2014. If you thrive in a brilliant, fast-paced, and mission-driven environment, Illumina is the place for you – imagine the possibilities.

Position Summary:

Illumina is looking for a driven, talented Engineering Manager to join our Consumables Manufacturing Validation Engineering group. As the leader of the Computer Software/System Validation team, this person will work in a dynamic, team-oriented environment and play a significant role in the implementation and validation of software/systems used in the consumables manufacturing lines. This person will lead a team of Validation Engineers to establish and maintain the validated state of the Computer Systems and Process Software utilized on the consumables manufacturing lines within the site and coordinate / support technology transfer to other sites, as needed. This leader will partner cross-functionally with R&D, Quality, Production, and other engineering groups in the design, development, launch and validation of new manufacturing process and will also provide support to manufacturing to satisfy the quality and process/software validation requirements for existing products in a rapid growth environment.

Responsibilities:

  • Provide leadership and direction to the consumables Process Engineering team to accomplish all team goals and objectives.
  • Maintain staff by recruiting, selecting, and training employees. Maintain a safe, secure, and legal work environment.
  • Manage team development through training, coaching and career mapping. Develop personal growth opportunities.
  • Work with Site Quality, Software Quality, Manufacturing/ Operational Excellence, Regulatory, and Engineering subject matter experts to prepare for and support FDA and other country-specific agency audits.
  • Assess new and existing systems and processes against cGMP and ISO 13485 requirements for process validation and determine when re-validation is required.
  • Ensure site/system validation program meets requirements of FDA (21 CFR Part 11 and 820), ISO (13485 and 14971)
  • Maintain validated state under Site Validation Master Plan and update Site Validation Master Plan as needed.
  • Collaborate with peers and stakeholders to identify opportunities for process improvement.
  • Facilitate communication and implementation of consistent processes across various product teams and global manufacturing sites.
  • Provide validation training to engineers, manufacturing technicians or other staff on validation protocols and standard operating procedures.
  • Coordinate and participate in development, testing, and implementation of interim and long-term processes and technology solutions including software testing and system level testing with new software.
  • Assist with development and review of system/software requirements to ensure testability.
  • Perform functional and process risk assessments in conjunction with Quality and Engineering subject matter experts.
  • Perform equipment IQ/OQ/PQ, gauge R&R (repeatability and reproducibility), test method validation, and spreadsheet validation.
  • Author software/system validation plans, protocols, and reports for consumables manufacturing and release.
  • Facilitate execution of validation protocols and review objective evidence for inclusion in validation reports.
  • Assist with documentation and resolution of deviances and variances that occur during validation.
  • Assist with determination of root cause, impact, and resolution of problems impacting production.
  • Partner cross-functionally with R & D, Quality, Manufacturing and other engineering groups to develop processes for new products and sustain and improve processes for existing products.
Requirements

Requirements:

  • Experience in the medical device/IVD or biotech/pharmaceutical industry in software/system validation, quality management, process controls, and continuous improvement methods.
  • 8-10 years in manufacturing, quality assurance, and/or software engineering/validation in an FDA-regulated environment.
  • Knowledge and working application of FDA cGMP/GCP regulations, ANSI/ISO standards, GAMP 5, and 21 CFR Part 11/820.
  • Knowledge and working application of FMEA and Risk Analyses.
  • Knowledge and working application of validation principles and guidelines and industry best practice.
  • Ability to multi-task and methodically manage projects in a fast-paced manufacturing environment.
  • Demonstrated ability to successfully lead, coach and mentor direct reports required.
  • High level problem solving and reasoning skills required.
  • Demonstrated analytical problem solving and interpersonal skills.
  • Ability to communicate effectively and accomplish goals while working across functions and organizational levels is required.
  • Ability to lead a team of validation engineers to successfully prioritize and manage multiple projects across several product lines.
  • Ability to manage consultants and set expectations for the quality and timeliness of their deliverables.
  • Excellent verbal and written communication/documentation skills.
  • Experience with product development processes and project management skills are required.
  • Good interdepartmental communication, influence and documentation skills are required.

Preferred Attributes:

  • ASQ accreditation, Lean Six Sigma, and/or PMP certification.
  • Experience with bioinformatics, statistics, Statistical Process Control, and/or Design of Experiments techniques.
  • Solid understanding of manufacturing processes in high-tech device manufacturing.
  • Experience with Microsoft Office, Microsoft Project, Visual Studio, SAP/ERP, and Manufacturing Execution Systems.
  • Experience working on multiple projects simultaneously.
  • Ability to quickly grasp complex technical topics.
  • Ability to discuss technical topics with non-technical people.

Education & Experience:

  • B.S./M.S./PhD in an engineering or science field with at least 7 years of relevant experience and at least 2 years as a technical manager in a cGMP environment.

Illumina believes that everyone has the ability to make an impact, and we are proud to be an equal opportunity employer committed to providing employment opportunity regardless of sex, race, creed, color, gender, religion, marital status, domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, sexual orientation, pregnancy, military or veteran status, citizenship status, and genetic information.

How to Apply

To apply for this position, please use the following URL:

https://ars2.equest.com/?response_id=e8575ab351accdd6fed11540ef359f0c

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