Compliance Specialist (Engineering & Automation)
We are currently looking to fill a Compliance Specialist (Engineering & Automation) position. This position ensures and supports cGMP and procedural compliance for the Technical Operations Engineering & Automation Department. This includes conducting evaluations against documents and providing mentorship to others on a variety of cGMP work.
In this role, a typical day might include the following:
Maintain knowledge of current good manufacturing practices (cGMPs), Biotech/Pharmaceutical industry rules/emerging draft guides (GxP), etc. and conduct department relevant evaluations against these documents.
Provide support, information and assistance with the initiation, authorship, completion and follow-up of department documentation and records such as change control, investigation, root cause analysis, risk assessment, impact statement, corrective/prevention action plan, standard operating procedure/work instruction/job aid, periodic evaluation report, logbook, maintenance record/work order, lifecycle document, policies, etc.
Perform periodic review/evaluation of these documents and records to assess for compliance with established quality/regulatory standards/requirements, policies and procedures. Teach/council department members in accurate execution.
Acts as a liaison between Engineering & Automation and Quality/Regulatory groups to identify and address compliance related issues.
Find opportunities for continuous improvement of compliance and support/lead improvement initiatives.
Author responses, and track/trend results of department quality/compliance and regulatory audits/inspections.
This role may be for you if you:
Have solid understanding of cGMP biotech/pharma manufacturing operations/laboratory testing, regulatory and quality requirements, Root Cause Determination and Risk Management Techniques, procedures and documentation methods.
Are able to manage multiple tasks and meet goals.
Are able to speak to large groups (including senior management and regulatory agencies).
Possess excellent writing, communication and interpersonal skills.
To be considered for this role you must hold a Bachelor’s degree in science or engineering and the following minimum amounts of related experience for each level:
Associate Specialist – 0-2+ years
Specialist – 2+ years
Senior Specialist – 5+ years
May substitute proven experience for education requirement. Level is determined based on qualifications relevant to the role.
Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for employees at all levels!
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.