Kelly Services Software Quality Engineer in Jacksonville, Florida

SOFTWARE QUALITY ENGINEER

LOCATION: Jacksonville, FL

DURATION: 6 Months

PAY RATE: $37-41.56/hr.

Our client, a manufacturer of contact lenses, currently has an IMMEDIATE need for a Software Quality Engineer responsible for managing the development & implementation of software validation policies and procedures, and managing /conducting software validation projects in support of existing computerized systems in the Jacksonville campus. Project responsibilities will be focused on medium to large validation projects. This position may also oversee software qualification activities related to contract repackaging and contract manufacturing projects.

This is a 6 month CONTRACT position, and it is located in Jacksonville, FL.

RESPONSIBILITIES:

Leads software validation activities/projects with specific focus to manufacturing systems. Creates, reviews and/or approves software validation documentation. (50%) Supports the global streamlining and standardization of SDLC & software validation policies, procedures and processes for computerized systems. Implements new or re-engineered software validation systems/ programs. Establish “live documents” process and remediation of legacy systems. (20%) Reviews and approves internal and vendor software development and test documentation, and conducts software vendor audits as needed. (5%) Develops and conducts SDLC/CSV training for IT and Operations. (10%) Monitors and evaluates changes to validated systems. (10%) Performs other related duties as assigned by management. (5%)

Other responsibilities:

Leading validation project planning COTS package evaluations Requirements gathering Performing sw risk assessments Executing and documenting qualification protocols & reports, reviewing/approving of software test cases/scripts, code reviews, Reviewing/approving software vendor package documentation Prioritizing and planning all assigned projects for the QA software validation department Implementing new or changed quality systems (programs/policies/procedures) Leading the design/development computerized systems Facilitating change validation as part of CCB (SQE rep) Developing CSV training modules and provide CSV training globally to OPS, QA and IM Leading the Installation Qualification (IQ) of 3GT/2GT manufacturing lines Supporting CSV improvement initiatives Monitor/evaluate changes to validated computerized systems and audit software vendors as needed. Lead the streamlining and standardization of Computerized Systems Validation (CSV) and SDLC programs globally, which includes links to OPS/IT/R&D business practices, 21 CFR Part 11, SW Risk Assessments, Business Continuity, Change Management, and Revalidation, to align with client’s World Class Compliance Plan. Support the remediation of legacy systems (per CSV/SDLC program) and establish a “live documents” process for relevant CSV/SDLC documents. Lead the development and implementation of CSV/SDLC training programs and provide CSV/SDLC training globally.

REQUIREMENTS:

Bachelors Degree in Engineering/Computer Science, Masters Degree preferred. Minimum 6 years work experience for Bachelors degree in Computer Science, Life Science, or Software Engineering, minimum 4 years work experience for Masters degree, with Validation focus within the Medical Device and/or Pharmaceutical Industries. Minimum 2 yrs work experience with SCADA and/or Manufacturing Control Systems Pharmaceutical experience preferred. Certified Software Quality Engineer (CSQE) certification from ASQ preferred. Professional memberships in IEEE. Excellent understanding and application of principles, concepts and practices of software validation methods, ISPE/GAMP 5, QSR/ISO regulations. Excellent communication, interpersonal, analytical and organization skills. Strong leadership and coaching skills. Experience with developing validation policies/procedures/guidance

Why Kelly?

Kelly® puts you in charge of your career, with access to cutting edge projects and technologies in industry leading organizations. Top companies throughout the world have trusted Kelly as a premier source of engineering talent and services since 1965. And engineering job seekers know Kelly® as a firm with an unmatched reputation for quality, integrity and professionalism. Whether you seek the variety and flexibility of working on short term project engagements, or prefer contract-to-hire or direct hire placement with our clients, apply with Kelly® to explore opportunities that suit your specific professional interests.

As a Kelly Services employee, you will have access to numerous perks, including:

Exposure to a variety of career opportunities as a result of our expansive network of client companies Career guides, information and tools to help you successfully position yourself throughout every stage of your career Access to more than 3,000 online training courses through our Kelly Learning Center Group-rate insurance options available immediately upon hire* Kelly-sponsored Affordable Care Act health care coverage available to eligible employees

· Service bonus plan

· Holiday pay plan

· Weekly electronic pay options

· Exclusive online employee community

· Employee assistance program available at no cost

· Corporate discounts

· Transportation Spending Accounts

*Offered and administered by Leslie & Associates. These plans are not sponsored by Kelly Services.

Let us help advance your career today.

*Available for purchase and administered by a designated third-party vendor

Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females, Individuals with Disabilities, Protected Veterans, Sexual Orientation, and Gender Identity, and is committed to employing a diverse workforce.

Why Kelly®? Kelly puts you in charge of your career, with access to cutting edge projects and technologies in industry leading organizations. Top companies throughout the world have trusted Kelly as a premier source of engineering talent and services since 1965. And engineering job seekers know Kelly as a firm with an unmatched reputation for quality, integrity and professionalism. Whether you seek the variety and flexibility of working on short term project engagements, or prefer contract-to-hire or direct hire placement with our clients, apply with Kelly to explore opportunities that suit your specific professional interests.

About Kelly Services®

As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2016 was $5.3 billion. Visit kellyservices.com and connect with us on Facebook, LinkedIn and Twitter.

Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females, Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is committed to employing a diverse workforce. Equal Employment Opportunity is The Law.]]

Category: Engineering