Sr. Automation & Engineering Compliance Specialist - Rensselaer, NY | Biospace
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Sr. Automation & Engineering Compliance Specialist

Regeneron Pharmaceuticals, Inc.

Rensselaer, NY
Posted Date:
Position Type:
Full time
Job Code:
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job Description

Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases.

Summary: Responsible for support of the Automation Periodic Evaluation Review (PER) Program for the Rensselaer Engineering/Automation Compliance Group. Responsibilities include, administration of PER Program execution control and monitoring, overseeing and monitoring progress to ensure timely and compliant completion, and advising and supporting PER Program team members. Will be required to apply experience and knowledge to identify areas of inefficiencies within PER Program using teamwork and collaboration and apply project solutions to improve program and processes. Will be required to complete more advanced and complex PERs in compliance with company standards, procedures and timelines.

Essential Duties and Responsibilities: include, but are not limited to, the following:
* Maintain current and complete understanding of the PER program and activities.
* Montior PER program execution, ensuring sufficient and timely progress is maintained, ensure due dates are met, troubleshoot/rectify issues and propose path for novel situtations with a continuous improvement and collateral mindset.
* Colloborate with cross-functional teams and facilitate consensus of solutions.
* Propose solutions and lead implementation of approved process improvements.
* Set priorities within defined responisbilities with limited supervision and adapt as priorities change.
* Provide support to team PER team as needs arise, including training,mentorship, and as an additional resource.
* May have direct reports.
* Interact with System Owners, System Administrators and Validation: gather feedback, address issues/concerns and act as liason for the PER team.
* Make quality decisions with limited supervision and work independently.
* Independently complete more advanced/complex PERs in compliance with company standards, procedures and timelines.


Education and Experience:
* Senior Level - BA/BS required, preferably in an engineering or scientific related field, with 5+ years of relevant experience (including 3+ years in Biotech/Pharmaceutical regulated/GMP environment); will substitute relevant experience in lieu of educational requirements.
* Knowledge and experience in/with Automation Administration or Validation Role (examples of systems within parenthesis): Manufacturing equipment (HMI, PLC), Analytical Laboratory instrumentation, Facility utilities (Historian Systems, BAS-Building Alarm Systems), Enterprise (BMRAM, Empower, QUMAS, LIMS, Oracle, SABA), etc.
* Strong GMP Technical Writing skills.
* Professional Communication; Team First Mentality.
* Experience in Project Management.
* Experience in completing Periodic Evaluation Reviews.
* Strong Knowledge of GAMP 5 and ISPE Standards.
* Experience in Continuious Improvement and Risk-Based Approach is be a strong plus.
* Strengths: Trust, Teamwork, Transparency, Respect, and Drive.

This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business.

To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid.

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.