Responsibilities

· Lead the design, development, implementation, and execution of test scripts/test plans to identify software problems and their causes.

· Coordinate and execute performance and functional testing associated with multiple concurrent development and/or infrastructure projects.

· Perform testing of the entire SDLC, including version/change control and new software rollouts.

· Develop releases on multiple platforms to ensure that all code released to production systems meet or exceed pre-defined quality standards.

· Author and execute Installation and Operational Qualification (IQ/OQ) protocols and reports for pharmaceutical manufacturing, packaging equipment and utilities equipment.

· Assist in the design and procurement of new process and utility equipment and lead installation, start-up and commissioning or qualification activities.

· Author IQ/OQ protocols for new or used equipment purchased.

· Review IQ/OQ protocols provided by equipment manufacturers to ensure compliance with site procedures.

· Utilize knowledge of all phases of Software Project Development Life Cycle and broad contribution to Analysis, Design, Development, Testing and Deployment of Software Applications.

· Ensure that the testing is sufficient to meet regulatory requirements (21 CFR Part 11, ISO 13485, ISO 14971).

Requirements

· BS in Engineering, Science, or equivalent technical degree.

· 7+ years’ experience in a regulated, manufacturing environment within the biotechnology, pharmaceutical or medical device industry.

· Excellent written and verbal communication skills; excellent technical writing skills.

· Strong interpersonal skills and the ability to work in a team environment.

· Ability to work effectively in a fast-paced multitasking environment.

· Strong working knowledge of FDA and cGMP regulations and documentation practices.

· Proficient in Microsoft Word, Excel, PowerPoint.

Compensation: $60,000.00 - $105,000.00 per year

TK-CHAIN® is a Lifesciences Consulting and Staffing Solutions company, helping pharmaceutical, biotechnology, medical devices, and clinical research companies streamline processes in drug and vaccine discovery, through proprietary systems, processes, and methodologies, TK-CHAIN® can map key customer problems, and offer customized solutions. Since the company began operations, it has enforced a performance-driven, and results-oriented culture, making it a reliable, and widely acclaimed partner for high-profile R & D client projects.

For more than 35 years of combined experience, companies have turned to TK-CHAIN for the highest caliber of talent solutions, knowing that we have an extensive network of global seasoned consultants that can be trusted to get the job done.

That’s because we know our consultants and the industries we serve. We constantly build new relationships through personal referrals and references to ensure the best and brightest minds are part of our TK-CHAIN talent network.

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