Sr Compliance Specialist (Engineering)
We are currently looking to fill a Sr Compliance Specialist (Engineering & Automation) position. This position ensures and supports cGMP compliance for the Engineering & Automation Department.
In this role, a typical day might include the following:
Leads, authors, and supports sophisticated investigations and root cause analysis for equipment, control system, lab system, and compliance-related events.
Owns complex change controls and authors technical documents in support of the change (ex, technical evaluations, test plans).
Provides tracking and trending of compliance activities (ex, change controls, investigations, and corrective and preventive actions).
Authors complex Periodic Evaluation Reports for automated process equipment, clean utilities, and lab systems.
Supports creating and updating Standard Operating Procedures, Work Instructions, Job Aids, Templates, Equipment Specifications, and System Design Specifications (ex, User Requirement Specifications, Functional Specifications, System Design Specifications).
Performs compliance review of executed work documented in CMMS (ex, Blue Mountain Regulatory Asset Manager).
Coordinates and assists Engineering & Automation department in preparation of regulatory inspections. Acts as a department liaison during regulatory inspections and coordinates post-inspection activities.
Acts as a liaison between Engineering & Automation and on-site Quality groups to address compliance-related items.
Maintain knowledge of current good manufacturing practices (cGMP) and biotech/pharmaceutical industry guidance (ex, ASME BPE, GAMP 5).
Identify and implement continuous improvements.
This role may be for you if you:
Have advanced knowledge of cGMP operations, regulatory, quality requirements, root cause analysis and risk evaluation.
Possess strong written and verbal communication skills.
Have working knowledge of equipment specification requirements.
Are able to work with minimal supervision/guidance.
Can review and understand engineering drawings.
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 working in a cGMP environment or in the operation of a regulated industrial facility 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.