Senior Validation Engineer - Indianapolis, IN, United States - Yoh

Description

Yoh is seeking a Sr. Validation Engineer (NON IT) for our well established pharmaceutical company. The Sr. Validation Engineer will mentor and support in the diagnoses and resolution of software, instrument, and process problems to maintain system readiness of both packaging equipment and data historian network. You will ensure site compliance and all vital activities are performed on time to keep all validated systems in a validated state. In this role, you will also create and implement the site's validation strategy. Location : Indianapolois, IN (On Site)
Type: Contract to Hire

Compensation : $35-40/hour DOE

Schedule : M-F, 8am-5pm

Responsibilities:

• Assess and define assigned validation projects.
• Liaise between engineering and quality assurance throughout validation lifecycle of packaging equipment and data historian network.
• Writing, reviewing, and implementing project validation protocols for standard & customized systems.
• Prepare validation summary reports for completed protocols.
• Conduct deviation investigations, such as validation failures, complaints, and hold investigations.
• Identify & implement the appropriate corrective actions.
• Author operational guidance documents (SOP/WI/JA/FORM) and conduct trainings.
• Partner with quality assurance team to participate in internal and external audits to defend equipment validation packages including calibration and maintenance.

Skills or Requirements:

• Demonstrated understanding of cGMP, GDP, and regulatory requirements for automated systems, CPPs, and CQAs, pFMEAs Knowledge, Skills, Abilities.
• Driven to successfully evaluate risks, opportunities, and roadblocks to make the best decisions to achieve your goals and the team's goals.
• Diligent collaborator whose comfortable influencing, informing, and instructing peers and members of the leadership team throughout all levels of the organization.
• Hands-on engineer with comfortability being present in and working in and around manufacturing areas and equipment.
• Experience with DeltaV or similar automation system preferred.
• Experience working with Trackwise, Maximo, and other electronic document management systems preferred.
• Experience applying Data Integrity Principles (ALCOA) as part of standard work preferred.

Education/Experience:

• BS Degree in Engineering or related field.
• Minimum of 3 years of validation experience in a regulated industry or equivalent validation experience that included the development and execution of FAT, SAT, and IQ/OQ protocols required.
• Pharmaceutical experience required.

#IND-SPG Note: Any pay ranges displayed are estimations. Actual pay is determined by an applicant's experience, technical expertise, and other qualifications as listed in the job description. All qualified applicants are welcome to apply. Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. Visit to contact us if you are an individual with a disability and require accommodation in the application process.