Senior Engineer, Facilities and Engineering (Relocation Assistance Available) - Florida, Gainesville

The announced job offer is made public by the firm: Inceptor Bio and it was included in jobs list the date of: 2022-10-22 in the website greenenergyjobsonline.com.

It is announced that they have a job offer at the category of Engineering and the jobs location is in the state of Florida at the city Gainesville, in the country US - at this current ZipCode: 32601

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Job Title: Senior Engineer

Team: Engineering

Reports To: Senior Director of Engineering and Validation

Classification: Exempt

Summary

The Senior Engineer will work closely with the Engineering team members, manufacturing, supply chain, Quality Assurance, R&D, Product Development, Analytical Development, and the QC laboratory. The role will be both project based and require day to day activities executing the engineering strategy commensurate with the overall site plan as outlined by the Senior Director of Engineering and Inceptor Bio.

Please note, Inceptor Bio, LLC. mandates COVID-19 vaccination of all employees. Accommodations may be made in accordance with applicable law.

Essential Duties and Responsibilities

• Manage small to large projects and tracking spending of budgets, creating scope of work, risk assessments, justification, cost estimates, implementing purchase order requisitions, contracts.
• Coordinate installation, engineering start-up, and validation activities of new equipment and systems including ability to draft and manage documentation of user requirement specifications, system impact assessments, IQ/OQ protocols, execution, and summary reports.
• Ensuring that facility additions/future work meets government regulations and environmental, health and security standards.
• Strong understanding of facilities related Environmental Health and Safety (EHS) beneficial.
• Performs all job duties and responsibilities in a compliant and ethical manner and in accordance with all applicable regulations, and industry codes.
• Assist or manage implementation and oversight of critical computerized maintenance and calibration systems.
• Assist or manage implementation and oversight of critical computerized environmental monitoring systems.
• Understanding of asset management, facilities and equipment maintenance and calibration systems beneficial but not required.
• Represent department in Project Team meetings, interact with project teams and cross-functional groups.
• Assist in vendor contact for third party maintenance and calibration activities.
• Assist in process transfer, optimization as required.

Qualifications

• Knowledge of GMP, FDA and EMA regulatory requirements applicable to Biologics including Cell/Gene/Viral therapy products as they pertain to maintenance and calibration is beneficial.
• Regulatory Knowledge CBER, CDER, CDRH and other global agencies is preferred.
• Strong knowledge of current industry trends and the ability to use the latest technologies is beneficial.

Required:

• Analytical and problem-solving skills required.
• Must have excellent communication skills and ability to work in a team-oriented environment.
• Hands-on contributor capable of understanding the validation, engineering, maintenance and calibration programs as well as requirements in the regulated industry.
• The individual must be capable of independent work. Required.
• Business setting and acumen. Required.
• Flexible, proficient in technical writing, strong interpersonal and communication skills required.
• Required: minimum of 3 years' experience in a GxP environment working with validation, engineering and facilities.
• Bachelor's degree in Engineering Science/Engineering discipline

Preferred:

• Preferred: 3+ years' experience in a GxP environment working with validation, engineering, process engineering and facilities.
• Graduate degree in Engineering Science/Engineering discipline
• An equivalent combination of education and experience may be considered.

Travel Requirements

• Travel requirement =
• The Job Title will be expected to travel to all applicable locations when needed.

Location

• This is an office-based position located at the Gainesville, FL site.

Inceptor Bio provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, amnesty, or status as a covered veteran in accordance with applicable, federal, state, and local laws. Inceptor Bio complies with applicable state and local laws governing non-discrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including, but not limited to, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.

NOTE TO EMPLOYMENT AGENCIES: Inceptor Bio values our relationships with our Recruitment Partners. We will only accept resumes from those partners who have been contracted by a member of our Human Resources team to collaborate with us. We are not responsible for any fees related to resumes that are unsolicited or are received without contract.