Loading...
 

Sr. Manager, Validation

Location: 

Canton, MA, US, 02021


 

Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life.

The Sr. Manager provides oversight of validation processes, manages, and develops employees, reviews documents for regulatory submission, participates in regulatory inspection and response activities, and is responsible for performance, resource and budget management This role sets the Commissioning and Qualification (C&Q) strategy for GxP production equipment, laboratory equipment, and utility systems at the Canton site. The Sr. Manager is responsible for the consistent application and maintenance of C&Q procedures and testing templates for site projects (both OPEX and CAPEX). The role supervises and reviews C&Q protocols and functional testing documentation, the subsequent execution of C&Q documentation and the drafting the resulting reports. This position requires validation technical knowledge in a variety of fields, budgetary, and solid written and oral communication skills.

 

ESSENTIAL FUNCTIONS
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.

•    Lead and develop staff personnel within the CQV function
•    Author, review and approve technical documents throughout the equipment/system lifecycle from commissioning and qualification through decommissioning and retirement.
•    Provides oversight of CQV processes including cleaning, sterilization and shipping.
•    Manages contractors and employees with various experience levels with capability to develop new leaders, individual contributors, and technical experts. 
•    Represents CQV and Emergent during FDA and other regulatory agency inspections. Interacts with contract, corporate, and governmental auditors. 
•    Complete FDA inspection response reports, monthly response updates and coordinated response and gap analysis teams. 
•    Validation approver of CTDs for submission to FDA (CBER) 
•    Develops validation systems, reviews commissioning and qualification reports for major projects such as the validation of new equipment or new manufacturing facilities. 
•    Develops and provides oversight for Project, Process, Cleaning, Equipment, and Facility master plans. 
•    Provides oversight, review and approves Validation SOPs and site Risk Analysis, Deviations, CAPAs and Change Controls. 
•    Plans and tracks budgetary requirements. Responsible for resource management and resource modeling for equipment, instrumentation, supplies, and personnel. Provides routine reports regarding budgetary updates and variances against approved budgets. 
•    Participates in review of contract negotiations for customers (specific to review of sections pertaining to Validation).
•    Define metrics that exhibit productivity and throughput in functional area and maintains metrics. Communicates metrics, trends, and data summaries to senior management using a variety of media: intranet, reports, and presentations. 
•    Provides technical oversight of the development of key documents including Impact Assessments, URS’s, Design Qualifications, Design Specifications, Trace Matrices, IOQ Protocols and Reports.
•    Ensure consistent documentation quality in support of both CAPEX and OPEX projects.
•    Confirm Emergent procedures and best practices are applied in all CQV activities.
•    Responsible for the updates to CQV platform methods and procedures.
•    Assists staff in the use and documentation of the Engineering Change Management Process
•    Mange the execution and documentation of functional tests, protocols and qualifications for new systems. 
•    Ensure team compliance managing Change Control plans within site Quality systems.
•    Participate in investigations of process system deviations and implement corrective and preventative actions as required to mitigate future recurrence. 
•    Participate in regulatory inspection and response activities.


The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management’s assignment of essential functions. 

 

MINIMUM EDUCATION, EXPERIENCE, SKILLS
•    BS in Engineering or science field. 
•    Minimum of 8 years of experience in a parenteral pharmaceutical cGMP quality experience with increasing responsibilities. 
•    Preferred minimum of five years supervisory experience. 
•    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.
•    Must have knowledge of steam in place (SIP) and Cleaning (CIP) operations.
•    Demonstrated success in independent judgment, technical proficiency and collaboration with others in a cGMP environment.
•    Must be a team player and able to work cross-functionally in a matrixed environment. 
•    Must have excellent written and verbal communications skills. Must be able to prepare reports for internal metrics and technical content and prepare reports and summaries for FDA review. 
•    Must have good communication skills, the ability to communicate clearly and extemporaneously to a variety of audience types. 
•    Excellent organizational and interpersonal skills.
•    Previous experience and working knowledge of Microsoft Project, Word, Excel and SAP desired.
 

Successful applicants for this position must be fully vaccinated against COVID-19 as a condition of employment. Individuals with qualifying medical issues or sincerely held religious beliefs or practices that may prevent them from getting the vaccine may request an exemption from the vaccine requirement.

 

There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate.

Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions.
 

Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce.  Emergent does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law.
 

Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy .
 

Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions’ approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions’ approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency.

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

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


Nearest Major Market: Boston