Engineer 2 - Quality Engineering

1 month ago

Titusville, United States The Fountain Group Full time

Pay: $43.75

Responsibilities:
Execution of PES supplier change control processes in conformance to current standards and procedures, using applicable system application tools.
Ensure integrity, consistency and compliance of processes for JSC globally.
Assure successful implementation of changes and actions by following up and synchronizing activities for all participants, communicating status for implementations to key stakeholders
Provide product and Supply Chain knowledge to ensure proper implementation and compliance
Partner with other areas of Supply Chain and actively develop and manage relationships with process users, business owners, Pharmaceutical affiliates and external organizations.
Non-negotiables: Feels confident speaking to others; has GMP background; Proficient in MS office (Trackwise experience would be beneficial); someone who is computer document driven; comfortable with moving records forward.

Job Qualifications:
Bsc in Physical or Life Science; Supply Chain and/or Chemical Engineering
3-5 years of related experience, including significant experience in pharmaceutical or other related highly regulated industry
Min. 3 years' experience in leading virtual teams
Strong Project Management Skills
Demonstrated experience to lead complex change implementations confidently.
Demonstrated understanding of manufacturing processes and associated GMP compliance requirements. Able to apply this knowledge to lead and develop change control process strategies for global needs
Demonstrated understanding of global Regulatory Affairs legislation and Regulatory Compliance requirements. Able to apply this knowledge to evaluate changes and assess potential risk introduced to the business as result of changes
Ability to engage and align with other diverse and dispersed organizations and functions.
Ability to negotiate, influence and lead without direct line authority.
Ability to engage others and lead an organization through continuous improvement and change.
Excellent communication (phone, e-mail) skills
Have attention to detail and are organized; follow and establish processes
Proficient in written and spoken English
Ability to work independently
Ability to understand the content of changes

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