Job Information
CSL Behring Senior C&Q Engineer in Kankakee, Illinois
Position Purpose:
The Senior Commissioning & Qualification (C&Q) Engineer plans, manages and executes process, equipment, facility and utilities commissioning and qualification activities, ensuring compliance with company standards and governmental regulatory requirements. This includes considering adequate risk-benefit aspects; investigating/troubleshooting C&Q problems; supporting resource planning and supporting regulatory audit activities. S(he) interacts with the Center of Excellence (CoE) C&Q group and supports the implementation of corporate C&Q policies on site.
This is an individual contributor role with supervisory responsibilities for small project teams consisting of external consultants/contractors supporting Capex, Opex, Process Improvements, Change Control, CAPA projects and related site initiatives/programs. This role plans, manages and executes commissioning and qualification activities in all Value Streams, Utilities Areas, and Manufacturing Support Areas (QC Laboratory, Warehouses, etc.) at the Kankakee site.
The Senior C&Q Engineer supports and understands C&Q needs for both, projects, and change activities. S(he) works independently with general supervision to achieve performance targets with direct impact on the Process Engineering organization serving the Kankakee site.
Main Responsibilities and Accountabilities
Accountable for planning, managing, and executing C&Q activities on site:
Assessment of C&Q requirements for changes and projects.
Accountable for planning, development, execution and closure of commissioning and qualification protocols in all Value Streams, Utilities Areas, and Manufacturing Support Areas (QC Laboratory, Warehouses, etc.) at the Kankakee site.
Responsible for ensuring that all manufacturing processes on site remain in a qualified state.
Support planning of adequate staffing for projects and routine/regularly recurring C&Q activities.
Support draft/review of documents required for registrations and adequate responses to regulators regarding C&Q topics.
Participate in the execution of risk assessments for the site manufacturing processes using defined risk management tools.
Conduct deviation investigations related to C&Q activities, including root cause analysis and CAPA definition as required.
Identify and close C&Q gaps on site to minimize compliance risks.
Participate in regulatory inspections for all C&Q related topics.
Under general supervision, plans and executes commissioning and qualification activities independently and in compliance with company standards and regulatory guidelines.
Provides technical advice on commissioning and qualification issues to all Value Streams, Utilities Areas, and Manufacturing Support Areas (QC Laboratory, Warehouses, etc.) at the Kankakee site.
Supports management of vendors, assessing, approving and managing compliance for approved vendors using local and global quality systems.
Assists in developing programs and standard operating procedures (SOPs) and provides technical support/training on commissioning and qualification requirements.
Communicates cross functionally regarding needs and status of assigned activities and project deliverables.
Collaborate with C&Q Center of Excellence (CoE):
Collaborates/aligns with CoE SMEs and CoE Strategy Leads on C&Q topics.
Responsible for providing input to and agreeing on new or changes to relevant C&Q concepts, procedures, policies, standards.
Responsible for applying C&Q procedures to ensure compliance with global standards and regulatory guidelines.
Executes the C&Q strategies defined by the Process Engineering leadership for projects and registrations (new license applications, extension of registrations, changes) in close collaboration with the C&Q CoE.
Supports continuous improvement and innovation for C&Q processes on site in close collaboration with the C&Q CoE.
Competencies and Capabilities:
Thinks beyond and maintains an external and strategic focus.
Builds bridges and helps teams develop collaboration.
Unleashes outcomes and creates an accountable work environment.
Ignites agility and instills personal flexibility in self and teams.
Inspires the future and ensures clarity around the strategy.
Applies practical knowledge of job area typically obtained through advanced education and work experience.
Works independently with general supervision to achieve operational targets with direct impact on departmental results.
Exhibits superior performance when facing problems that are difficult but typically not complex and require understanding of a broader set of issues.
Influences others within the job area and cross functionally through explanation of facts, policies, and practices.
Leads/supervises small project teams of consultants/contractors engaged in C&Q activities.
Education:
- Degree in Engineering or a relevant scientific discipline (Chemistry, Biology, Microbiology, etc.).
Experience:
5+ years of experience in engineering/quality systems/validation/manufacturing in pharmaceutical manufacturing/a highly regulated industry. 1+ years of C&Q, Validation, Manufacturing, Quality Assurance, Engineering or Operations in a cGMP environment.
Knowledge and experience with biologicals and aseptic processing.
Knowledge of Project Management best practices.
Knowledge of current regulations and guidelines, industry standards and best practices for C&Q of biopharmaceutical products/processes.
Knowledge of current Good Manufacturing Practices (cGMP)
Knowledge of FDA and EMA requirements.
Experience with relevant interactions with FDA and EMA regulatory bodies highly desired.
Experience with plasma-derived products, CSV, Utilities Qualification, Cleanroom Qualification, Moist Heat Sterilization, Dry Heat Sterilization, Fill & Finish and/or VHP cycles is highly desired.
Our Benefits
CSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals.
Please take the time to review our benefits site (https://www.cslbenefits.com/csl/candidates) to see what’s available to you as a CSL employee.
About CSL Behring
CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring (https://www.cslbehring.com/our-company) .
We want CSL to reflect the world around us
As a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion (https://www.cslbehring.com/careers/diversity-and-inclusion) at CSL.
Do work that matters at CSL Behring!
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CSL makes all employment decisions without regard to race, color, religion, national origin, ancestry, age, sex, gender, pregnancy, disability, marital status, sexual orientation, gender identity, genetic information, military status, protected veteran status (specifically status as a disabled veteran, recently separated veteran, armed forces service medal veteran, or active duty wartime or campaign badge veteran) or other classification protected by applicable US federal, state or local law. CSL complies with all applicable employment laws, including but not limited to Title VII of the Civil Rights Act of 1964, the Americans with Disabilities Act, the Fair Labor Standards Act, and the Immigration Reform and Control Act. https://www.cslbehring.com/careers/eeo-statement