Senior Manager, Engineering & Validation

Durham County, NC - USA

Monthly Salary: Not Disclosed

Posted on: Yesterday

Vacancies: 1 Vacancy

Department:

Engineering

Job Summary

Position Overview

Senior Manager Engineering and Validation is recognized both as the technical subject matter expert and leader of the Engineering and Validation team at FLBU. The position will ensure that deliverables for the Engineering group are well established and in line with their stakeholders expectations. The team consists of Process/Production and Validation engineers supporting Operations as well as resources managing Engineering Document Control. Expectations of the position are to manage between 5-10 full-time employees as well as the contractors that support their efforts establish expectations for the team and provide direction for the activities that will support overall site goals.

Reporting directly to the Head of Engineering and Facilities the Senior Manager Engineering and Validation oversees the day-to-day activities of the Engineering group as well as the implementation of new technology and modifications to existing systems aimed at cost reduction efficiency improvements system sustainability and quality/safety enhancement. The team is responsible for supporting process equipment troubleshooting on the manufacturing floor during production supporting new equipment introduction design aspects validation activities around new equipment introduction and existing equipment re-qualifications engineering document management and operational and capital projects on site.

The team is responsible for processing equipment for fermentation and cell culture biologics processes including upstream and downstream equipment as well as support equipment such as Autoclaves Glasswashers etc. and the team should have expertise in these areas.

Company Overview

At FUJIFILM Biotechnologies were leading the charge in advancing tomorrows medicines. If you want to be a part of life-impacting projects alongside todays most innovative biopharmaceutical companies FUJIFILM Biotechnologies could be the right place for you.

From our Bioprocess Innovation Center to our cGMP-compliant manufacturing site we thrive on collaboration creativity and purpose. Whether your expertise lies in research manufacturing or production youll find a home here where your efforts directly improve patients lives. Together lets shape the future of healthcare.

Situated at the cross-section of Morrisville and Research Triangle Park (RTP) North Carolina our site is at the heart of a booming biotech hub surrounded by top universities vibrant communities and various outdoor opportunities.

Fujifilm is globally headquartered in Tokyo with over 70000 employees across four key business segments of healthcare electronics business innovation and imaging. We are guided and united by our Group Purpose of giving our world more smiles. Visit: Description

What Youll Do

Responsible for a team of Process/Production and Validation engineers and Engineering Document Control specialists in support of the site and departmental goals
Develop and manage team members performance and capabilities while providing formal and informal feedback to direct reports
Assures team activities are carried out in a manner of compliance with FDBU standards and cGMP regulatory requirements
Coaches team members in a learning culture with the goal of achieving employee empowerment and ownership
Establishes team objectives and ensures alignment with site and departmental goals
Interface and build collaborative partnerships with key site functions including Manufacturing Technical Operations Automation and Quality to deliver site goals and objectives
Actively manage contractor activities to ensure work quality and safe practices to facilitate contractor training
Provide training or presentations on automation systems and tasks to all site personnel
Provide hands-on detailed diagnostics/troubleshooting support to manufacturing development and automated equipment
Assess equipment and control systems to design and implement sound engineering solutions for mitigating existing operational issues drive continuous improvement and introduce new technology in accordance with FDBU standards and cGMP regulatory requirements While following GAMP guidelines
Independently manage or provide the support required for capital projects from conception design and initial specifications through completion and turnover. This includes developing detailed and accurate project schedules while collaborating with internal cross-functional teams end users and third-party contacts to maintain project deliverables concurrently with a dynamic workload based on site priorities.
Update and develop User Requirement Specification Functional Specifications Design Specifications and Guidelines for new and existing equipment and control systems
Generate and execute IOQs and PQs for new and revised processes and equipment
Develop mentor and train team members on equipment functionality troubleshooting and diagnostic techniques to enhance the overall capability of the group
Develop revise and abide by standard operating procedures and engineering documents
Lead support and perform investigations relating to complex manufacturing deviations and anomalies associated with processing equipment to properly identify root causes and implement appropriate corrective and preventative actions to prevent reoccurrence.
Provide process and validation subject matter expertise for regulatory inspections and interact with auditors as required
Other duties as assigned

Knowledge and Skills

Thorough understanding of pharmaceutical processing equipment knowledge in cell culture processing equipment preferred
Demonstrated knowledge of cGMP practices and equipment lifecycle processes
Knowledge of Commissioning Qualification and Validation best practices and functionality
Working knowledge of process control and equipment automation in biotech or pharmaceutical manufacturing facility
Display a solid understanding of theories/practices utilized by other disciplines outside the primary area of expertise (e.g. automation manufacturing quality etc.)
Solid understanding of relevant pharmaceutical PAT initiatives and the impact on regulatory guidelines
Demonstrated project management skills for ensuring project delivery to customer expectations. schedule and budget

Basic Requirements

B.S. Degree in Chemical Electrical Mechanical or similar Engineering with 10 years experience in relevant engineering and/or pharmaceutical manufacturing operations and 5 years experience leading or managing people and teams.
M.S. Degree in Chemical Electrical Mechanical or similar Engineering with 7 years experience in relevant engineering and/or pharmaceutical manufacturing operations and 3 years experience leading or managing people and teams.

Additional Requirements

Demonstrated leadership interpersonal technical aptitude and problem-solving skills. Strong team-building skills including the ability to coach/develop work teams provide training motivate/empower others and resolve conflict.
Flexible and able to manage multiple priorities and projects
Results-driven and goal-oriented with the ability to manage risks
Hands-on active management style while maintaining awareness of team activities
Excellent organizational verbal and written communication skills with the ability to effectively communicate within cross-functional teams and with upper management
Ability to organize and present technical overview to engineering staff cross-functional departments and upper management.
Maintains effective relationships across functional units gaining their trust and respect
Puts accomplishing the goals of the group ahead of accomplishing individual goals
Openly shares knowledge/information needed to accomplish a task or solve a problem
Exhibits professionalism and sets an example for others to follow
Self-starter and detail-oriented
Ability to manage commitments for self and the team while displaying an eagerness to learn and continuously improve
Ability to discuss normally encountered technical issues both verbally and in writing in a manner that is understood by non-technical personnel

Preferred Certifications:

Project Management Professional (PMP)
Lean/Six Sigma (Green/Black Belt)
Professional Engineer (PE)

Working Conditions & Physical Requirements:

The position requires essential physical abilities including but not limited to stooping kneeling crouching reaching standing walking lifting fingering grasping feeling talking and hearing. The 1nd1v1dual may need to exert physical effort such as moving light objects up to 20 pounds occasionally 10 pounds frequently and/or a negligible amount constantly.
The individual in this position should have the visual acuity required to perform activities such as preparing and analyzing data and figures; transcribing; viewing a computer terminal: extensive reading: visual inspection involving minor defects small parts and/or using measurement devices at distances close to the eyes Additionally this individual must have the visual acuity to determine the accuracy neatness and thoroughness of work assigned or to make general observations of facilities or structures
The individual in this position works in both environmental conditions: Actvities occur inside and outside

To all agencies: Please no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email the internet or in any form and/or method will be deemed the sole property of FUJIFILM unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired no fee or payment of any kind will be paid.

*#LI-Hybrid

EEO Information

Fujifilm is committedto providing equal opportunities in hiring promotion and advancement compensation benefits and training regardless of nationality age gender sexual orientation or gender identity race ethnicity religion political creed ideology national or social origin disability veteran status etc.

ADA Information

If you require reasonable accommodation in completing this application interviewing completing any pre-employment testing or otherwise participating in the employee selection process please direct your inquiries to our HR Department ().

Required Experience:

Senior Manager

Position OverviewSenior Manager Engineering and Validation is recognized both as the technical subject matter expert and leader of the Engineering and Validation team at FLBU. The position will ensure that deliverables for the Engineering group are well established and in line with their stakeholder...