Software Validation Engineer
Verona, WI 
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Posted 11 days ago
Job Description
OUR COMPANY:

Coating Place, Inc. has been in the contract manufacturing industry for the last 40 years. Our continued goal to provide the highest quality Wurster processing has kept us at the forefront of the “fluid bed micro-encapsulation” market. Our company mission helps us to maintain this focus.

“Coating Place is an established pharmaceutical contract manufacturer specializing in Wurster fluid bed processing and delivery system development. We provide our customers with modified and extended release bulk active products through innovative development and manufacturing capabilities with an integrated quality philosophy.”
It is our mission to continue urging the next generation, candidates like you, into these fields and further expand the capabilities of the industry through their capabilities.


Coating Place is a stable and growing company that offers a friendly work environment and an incredibly competitive benefits package including: health, dental, and vision insurance, a generous paid time off program to help balance work and personal life, and pre-tax 401(k) and after-tax Roth 401(k) contribution options with the company matching up to 5% of gross wages that is 100% vested at the time it is added to the employee’s account. In addition, Coating Place may choose to make a profit sharing contribution to your account!

POSITION OVERVIEW:

The Software Validation Engineer is primarily responsible for managing and executing the software validation program by working collaboratively with other departments to ensure the validation of bespoke and commercial off-the-shelf software packages are in compliance with FDA regulations.

ESSENTIAL JOB FUNCTIONS:
  • Participate in cross-functional projects to validate bespoke and commercial off-the-shelf software by assisting in the creation or review of user requirements, validation plans, design specifications, traceability matrixes, software configurations, testing protocols and summary reports.
  • Assist with establishing, reviewing, executing, and ensuring compliance with regulatory requirements, policies, and procedures related to software validation activities.
  • Prepare validation test strategies for validation initiatives by working collaboratively with project teams, advising on the design of the testing phases, and developing test plans based on risk.
  • Lead system risk assessments for software validation projects to ensure an efficient and cost effective approach that will ensure fitness for use and compliance to regulations.
  • Ensure that all necessary validation documentation is produced and reviewed for correctness, completeness, and clarity
  • Perform software vendor assessments
  • Assist in the purchase of new software products by assessing each for compliance to 21CFR Part 11 and data integrity gaps.
  • Manage the software change control system.
  • Assess software changes for impact to the system or any integrated systems and review all testing related to the changes.
  • Recommend, plan, lead software validation improvement projects
  • Writes/Revises and reviews relevant SOPs.
  • Follows all CPI safety practices, policies, and procedures.
  • Other duties as assigned.

EDUCATION/SKILLS/KNOWLEDGE REQUIRED:
  • Bachelor’s Degree, preferably in Information Technology or related field
  • 5+ years in a FDA regulated industry using validation best practices, preferably in the pharmaceutical or medical device industry
  • Demonstrated knowledge of cGMPs, 21CFR Part 11, GAMP5, Data Integrity, and other related regulatory agency guidances
  • SQE Certification or willingness to pursue the certification
  • Ability to communicate both verbally and in writing across all levels of the organization
  • Ability to maintain effective cross-departmental working relationships
  • Excellent organizational and multi-tasking skills
  • Ability to handle multiple projects
  • Proven project management experience
  • Sound practical judgement of priorities and high attention to detail
  • A continuous improvement and quality mindset
  • A willingness to develop themselves and teach others within and outside the department

 

Job Summary
Start Date
ASAP
Employment Term and Type
Regular, Full Time
Hours per Week
40
Work Hours (i.e. shift)
8am-5pm
Salary and Benefits
Sign On Bonus- 50% paid out after formal completion of initial training, 50% paid out after 1st year of service.
Required Education
Bachelor's Degree
Required Experience
5+ years
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