We are currently looking to fill a Principal Compliance Specialist – Engineering & Automation position. This position ensures and supports cGMP and procedural compliance for the Rensselaer Technical Operations Engineering & Automation Department. This includes conducting evaluations against documents and providing guidance to others on a variety of cGMP work.
In this role, a typical day might include the following:
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Maintain knowledge of current good manufacturing practices (cGMPs), Biotech/Pharmaceutical industry guidance/emerging draft guides (GxP), etc. and conduct department relevant evaluations against these documents.
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Provide support, information/guidance 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.
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Perform periodic review/evaluation of these documents and records to assess for compliance with established quality/regulatory standards/requirements, policies/guidance and procedures. Instruct/council department members in proper execution.
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Acts as a liaison between Engineering & Automation and Quality/Regulatory groups to identify and address compliance related issues.
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Identify opportunities for continuous improvement of compliance and support/lead improvement initiatives.
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Support coordination activities associated with audits/inspections, author responses, and track/trend results of department quality/compliance and regulatory audits/inspections.
This role may be for you if you:
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Strong Knowledge of cGMP biotech/pharma manufacturing operations/laboratory testing, regulatory and quality requirements/guidance, Root Cause Determination and Risk Management Techniques, procedures and documentation methods.
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Ability to manage multiple tasks and meet deadlines.
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Ability to speak to large groups (including senior management and regulatory agencies).
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Ability to work independently and manage projects.
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Excellent writing, communication and interpersonal skills.
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Working knowledge of word processing, spreadsheet, PowerPoint and database management software.
To be considered for this role you must hold a Bachelor’s degree, preferably in an engineering or scientific related field, and the following minimum amounts of relevant experience for each level:
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Senior Specialist – 5+ years
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Principal Specialist - 8+ years
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Staff Specialist - 10+ 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 step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible 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 parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.
For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.
Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
Salary Range (annually)
$77,600.00 - $173,400.00
Top Skills
What We Do
At Regeneron we believe that when the right idea finds the right team, powerful change is possible. As we work across our expanding global network to invent, develop and commercialize life-transforming medicines for people with serious diseases, we’re establishing new ways to think about science, manufacturing and commercialization. And new ways to think about health. Connect with us so we can learn more about you, and you can learn more about our biopharmaceutical medicines. And join us, as we build a future we believe in.
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