Sr. Manager, Validation - Lansing - Emergent BioSolutions

Description

Emergent BioSolutions is committed to assisting employees achieve their professional goals. Internal job postings are one of the tools available to employees at Emergent BioSolutions to assist in their career management. This enables current employees who have remained in their current position for a minimum of one year to apply for an open position.
I. JOB SUMMARY
Lead the Commissioning, Qualification and Validation (CQV), Cleaning, Sterility assurance and Computer System Validation (CSV) teams at a site. Serve as a member on project steering, value stream and quality systems performance teams. Establish operational objectives and systems to drive employee engagement and alignment with other departments. Deliver on site objectives while implementing harmonized engineering systems and processes. Provide leadership support to the other sites and global validation initiatives as needed.
II. ESSENTIAL FUNCTIONS
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
Site Leadership and Strategy

• Provide leadership and direction to Validation team members, driving performance and value creation to the site function operational and strategic plans and tasks

• Ensure adequate resourcing (capacity and capability) to accomplish site and OST objectives. Recommend solutions to alleviate constraints

• Regularly interacts with senior management or executives on multi-department projects and challenges. Able to build coalitions for change.

• Continuously improve the culture of the Validation team and the site

• Represents Validation and Emergent during GMP and other regulatory agency inspections (CDC, OSHA, etc.)
EFV Tactical Operations

• Identify areas to drive down operations costs and improve project delivery efficiency. Develop specific investment strategies to realize these savings

• Hands on troubleshooting and problem solving at the Gemba in support of engineering team members and operations

• Develop and lead small and medium sized continuous improvement projects, remain involved in projects led by staff members

• Direct support to OST head or lead annual OPEX budget for Validation department
Staff and System Development

• Effective delegation and building confidence and competence within direct reports

• Drive engagement in the technical and personal development of the Validation team and members

• Develops strong relationships with partners (QA, Mfg., etc.) and cultivates these with all team members

• Provide effective and collaborative cross functional leadership to facilitate development of the site strategy and delivery of site objectives

• Continuously improve the culture of the Validation team and the site
The above statements are intended to describe the general nature of work performed by those in this job. It is not an exhaustive list of all duties, and other duties may be assigned.
III. MINIMUM EDUCATION, EXPERIENCE, SKILLS

• BS in Engineering, Science, Management, or equivalent experience

• A minimum of 8 years of experience in a biopharmaceutical or related environment in an engineering or quality related role, with at least 3 years in a leadership role

• Significant hands on experience and regulatory expectations knowledge with controls, automation and computer system validation.

• Knowledge of pharmaceutical equipment, such as bioreactors, centrifuges, CIP skids, autoclaves, parts washers, HVAC systems, building chillers, clean steam generators, WFI generation, storage, and distribution, RODI water system, and Temperature Controlled Units (e.g. refrigerators, freezers, and incubators) is an advantage

• Strong track record of researching industry best practice (ISPE, BPOG, etc.) and partnering with engineering firms and consultants to develop and deliver effective and compliant projects
#LI-Hybrid
If the hiring manager expresses an interest in interviewing you for the open position, you must discuss your interest in the open position with your current manager prior to an interview being scheduled.
U.S. Base Pay Ranges and Benefits Information
The estimated annual base salary as a new hire for this position ranges from $129,500 to $156,800. Individual base pay depends on various factors such as applicant's education, experience, skills, and abilities, as well as internal equity and alignment with market data. The salary may also be adjusted based on applicant's geographic location. Certain roles are eligible for additional incentive compensation, including merit increases, annual bonus, [and/or long-term incentives in the form of stock options.]
Additionally, Emergent offers a comprehensive benefits package*. Information regarding additional benefits can be found here:
(*Eligibility for benefits is governed by the applicable plan documents and policies).
If you are selected for an interview, please feel welcome to speak to a Human Resources Partner about our compensation philosophy and available benefits.
ABOUT EMERGENT
Protecting and Enhancing 1 billion lives by 2030 focuses our energy to improve the quality of life for individuals around the world, giving them the opportunity to experience the fullness of life.
Our drive towards this vision informs all of our actions-whether it is our approach to product development, manufacturing, encouraging employee health and wellness or giving back to the community-we strive every day to achieve this shared goal.
WE BELIEVE IN OUR VALUES

• Lead with Integrity
  • We gain trust and confidence through ethics, quality, and compliance excellence
• Stand shoulder to shoulder no matter what
  • We combine our best thinking and communicate openly to support each other.
• Own it always
  • Every person at Emergent is engaged and accountable for delivering on our commitments.
• Break through thinking
  • We take smart risks, pursue innovation and challenge ourselves to constantly improve.
• Compete where it counts
  • We set the right goals and respect each other as we conquer them together.