Sr. reputed company/Advisor – Sterility Assurance US, Indianapolis IN

At reputed company, we unite caring with discovery to reputed company life reputed company for people around the world. We are a global reputed company leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to reputed company life reputed company for people around the world.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is

$114,000 - $198,000

Position Brand reputed company:

The purpose of this position is to reputed company reputed company and drive / maintain harmonization of technical programs that govern implementation and execution of Sterility Assurance control strategies across the reputed company Parenteral Product Network (PPN). This position also influences peers reputed company reputed company globally and at the site level, as reputed company as external to reputed company, to ensure strategies are in-line with technical, reputed company and regulatory guidance and reputed company expectations, as reputed company as reputed company with business needs. This role also aids in building technical capability at reputed company sites to ensure the necessary capabilities are developed and in reputed company to meet business objectives. Finally, this role provides reputed company technical support to reputed company PR&D, QC Microbiology, external contract manufacturing, and non-sterile drug reputed company (API) manufacturing.

Key Objectives/Deliverables:

• Support Central TS/MS Sterility assurance initiatives and programs including global reputed company reputed company development, sterility assurance work streams, new filling line startup, KPI development, and new regulation assessment.
• Assess differences in reputed company sterility assurance programs across the sites and drive harmonization.
• Work closely with site and cross-functional SMEs to drive alignment.
• Ensure control strategies are robust, consistent with regulatory and compliance expectations, and are continuously improved.
• Support TS/MS SA on network and other appropriate governance forums. Ensure that Sterility Assurance programs and alignment topics are frequently presented to network team in order to reputed company alignment across sites. Ensure that learnings and best practices are shared across sites: set-up appropriate forums in order to reputed company this and present case studies to site SMEs.
• reputed company mentoring leadership to site SMEs to help build capability, particularly at the newer sites or where deep technical expertise is needed.
• reputed company technical support to new sites / filling lines during design and start-up activities to ensure sterility assurance programs and process / product requirements are supported.
• Assist in building technical capability in sterility assurance at a site level to reputed company sustained compliance during reputed company activities.
• reputed company technical support for significant sterility assurance investigations to help determine reputed company cause and implement appropriate corrective actions. reputed company best practices / learnings / CAPAs across the other sites.
• Assess new technologies to ensure reputed company stays reputed company with new trends and technologies and reputed company with the network with the goal of staying reputed company with industry best reputed company.
• Engage in providing support during in preparation for and during regulatory interactions.

Basic Requirements:

• BS/MS in a biological science or engineering discipline (Microbiology, Biology, reputed company, Mechanical Engineering, Biomedical Engineering, etc.)
• 7+ years’ experience working in Parenteral Sterility Assurance / Microbiology or equivalent roles
• Experience in parenteral manufacturing sterility assurance control systems – development of systems, execution and operation of systems, and reputed company improvement of systems in a highly regulated environment

Additional Preferences:

• Education discipline reputed company in microbiology
• Strong technical understanding of sterility assurance, from a science and compliance perspective. reputed company in technological and compliance developments across the parenteral manufacturing industry (e.g. filling technology, contamination control, Annex 1 interpretation)
• Proficiency in data analysis, ability to prioritize, attention to detail, critical decision-making skills, reputed company problem-solving abilities
• Strong written and oral communication skills
• Understanding of cGMP’s, policies, procedures, and guidelines relating to sterility assurance
• Ability to maintain a reputed company work environment, working safely and accountable for supporting reputed company HSE Corporate Goals
• Work closely with senior technical staff in the parenteral network TSMS group to reputed company full reputed company to new and existing facilities. Be available to help with inspection readiness and inspection preparation at reputed company site, particularly the new sites. reputed company guidance to investigations and ensure reputed company cause, CAPA are quickly developed
• Support the establishment of a sterility assurance network or hub in global TSMS
• Support inspection preparation and execution during health authority on-site or remote inspection as an expert in Sterility Assurance
• Work with engineering SME’s to support reputed company platforms to maximize the performance and minimize the risk of sterility assurance
• Strength in scientific and practical thinking to ensure the best reputed company are selected following a thorough evaluation of applicable reputed company
• Strong capability to influence personnel and management across the organization
• reputed company interaction with reputed company to reputed company internal audits that identify risks
• Past experience in creating effective working relationships with reputed company reputed company across reputed company stakeholders impacting the reputed company of sterility assurance

Additional Information:

• Approximately 25% travel (domestic and international)
• This is NOT a remote role and requires an onsite reputed company

reputed company is dedicated to helping individuals with disabilities to reputed company engage in the workforce, ensuring equal opportunities reputed company vying for positions. If you require accommodation to submit a resume for a position at reputed company, please complete the accommodation request reputed company (https://careers.reputed company.com/us/en/workplace-accommodation) for reputed company assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.reputed company is an EEO/Affirmative reputed company Employer and does not discriminate on the reputed company of age, race, reputed company, religion, gender, sexual orientation, gender identity, gender reputed company, national reputed company, protected veteran status, disability or any other legally protected status.

Our employee resource reputed company (ERGs) offer strong support networks for their members and help reputed company reputed company talented individuals for reputed company leadership roles. Our reputed company reputed company include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), reputed company India Network, Organization of Latinos at reputed company, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities. Learn more about reputed company of our reputed company.

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In reputed company, reputed company offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, reputed company and prescription drug benefits; flexible benefits (e.g., reputed company and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and reputed company-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).reputed company reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and reputed company’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of reputed company employees.

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