Business Introduction At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicin…
Skills: Network integration, Cyber security, Data integrity, Computer system validation, Project management
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Principal Security Engineer, Product & Application
Cambridge, Massachusetts, United States · Hybrid
Senior+$853M raised
We're hiring a Principal Security Engineer I, Product & Application to own the security architecture of CMT's products. In this highly autonomous individual contributor role, you'll set the technical direction for produc…
Principal Security Engineer, Cloud & Infrastructure
Cambridge, Massachusetts, United States · Hybrid
Senior$853M raised
We're hiring a Principal Security Engineer I, Cloud & Infrastructure to own the security architecture of CMT's products, from our mobile SDKs and APIs to the services that power our platform. This is a highly autonomous …
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$120k–$199k/yr
Full-time
bachelor degree
Health care, Insurance benefits, Retirement benefits, Paid holidays, Vacation, Paid caregiver leave
Posted 19d ago
~40 hrs/week
Responsibilities
The Lab Systems Manager will lead the definition of network integration strategies for R&D computerized systems while ensuring compliance with cyber security and data integrity standards. They will act as the technical owner for validated systems, managing the full life cycle and coordinating with cross-functional teams to support R&D scientific platforms.
Requirements
Candidates must hold a degree in Life Science, Engineering, or equivalent, with at least 5 years of experience in managing IT or automation teams. Advanced knowledge of IT industry standards, network integration for lab systems, and experience with GAMP or CFR 21 regulations are required.
Full job description
Business Introduction
At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people’s lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients’ needs and have the highest probability of success. We’re uniting science, technology, and talent to get ahead of disease together.
The senior technical expert will actively contribute for the definition of network integration strategies for R&D computerized systems, in line with GSK Tech rules and policies, based on business requirements and following QA recommendations.
Ensure identification and application strategy of appropriate OT/Cyber Security controls for CAPEX projects
As R&D point of contact for Tech Strategies and Risk group (Accountable for Cyber Security at GSK), provides expertise support in the implementation of GSK Vaccines OT Security requirements
You will work in partnership with a broad range of stakeholder groups such as Quality, Computer System Validation, Tech, Procurement and R&D scientific platforms to foster Innovation and proactively define standards, identify cost saving opportunities and accelerate generation of scientific results
Manage internal network of local and global experts and ensure sharing of best practice and learnings in area of expertise
For systems used in non-regulated environment, will define and/or review technical mitigation and remediation strategies, leading to the respect of the Data Integrity principles, by monitoring and assessing industry trends, new solutions on the market, but also evolving regulatory expectations
For systems used in a regulated (GxP) environment, defines and approves, as Technical Owner, the Integration, Configuration and Life Cycle Management for validated systems. She/he will lead/ be accountable for activities such as technical Audit preparation, Periodic reviews, Services Catalogue upgrades, Change Management, etc.
Key responsibilities include:
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:
With a high degree of autonomy and in a team of IT-skilled profiles, dedicated to the management of computerized lab systems:
Ensures for CAPEX projects, the definition of landscape design for “computerized system(s)”, in respect to Tech rules, but also to Data Integrity and Cyber Security standards
Leads integration of complex Client-Server solutions, cross-platforms or cross-sites
Communicates & shares detailed knowledge of best practices & current trends, acquired both internally & externally on Cyber Security Threats and Protection
Embeds Cyber Security into all solutions and ways-of-working along the system’s life cycle
Defines plans for “Systems’ Life Cycle Management” aspects, such as:
Ensures creation of integration and configuration documents: Design specifications, Installation Scenario, Post-Installation Guide the activation/ configuration of specific modules such as Access Management, Audit Trail, etc. in collaboration with business, QA and CSV
Review/Approve “validation documentation” and other deliverables in the scope of the release and validation of R&D Computerized Systems (non-GxP as well as GxP)
For new computerized systems, define the best network integration strategy in collaboration with the equipment supplier, Tech, QA and CSV
Review/analysis of user requirements and computerized systems specifications prior to equipment purchase. Provide technical recommendations and highlight integrationand/or configuration constraints based on Tech, CSV and Data integrity rules and policies
Lead and coordinate activities such as Periodic reviews, Services Catalogue upgrades, Change Management, etc.
Ensures prioritization of operational activities according to Business requirements and available capacity within the team (GSK staff as well as external workforce)
Review/Approve “qualification/validation documentation” of R&D Computerized Systems
In the context of the Data Integrity program in R&D, ensures the feasibility and detaileddefinition of the technical mitigations to put in place for non-compliant ComputerizedSystems.
Ensures efficient and effective coordination of activities with the Functional ServicesProvider, including definition of guidelines on the expected technical solutions to bedelivered
Create SOP/WKI and other guidance documents in the field of expertise
Lab Systems Integration (Tech Infrastructure, Network, etc.)
Analytical Software Management
Application of Cybersecurity mitigations and standards
Data Integrity mitigations and remediations
Cover the role of “OT Custodian” for Vx R&D that includes below activities:
Establish and maintain effective lines of communications with the Tech service owner
Ensure that changes to the service provision are properly reflected in OT securitycontrols
Agree any proposed site-specific or asset related exceptions to OTESSs (OT Enabling ServiceSpecifications)
Take said exceptions to OTN-CAB for review and approval
Why you?
Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
Degree in Life science, engineering or equivalent experience
5+ years’ experience in management of IT or Automation team/project
Expertise in defining network integration solutions for computerized lab systems
Experience and advanced knowledge in IT industry standards and practices
Preferred Qualifications:
If you have the following characteristics, it would be a plus:
Proven experience in the field of analytical lab equipment (e.g. GAMP, CFR 21)
Highly comfortable with working in a diverse, ambiguous and a fast-paced environment.
Ability to manage risks, define risk-based strategies.
Ability to challenge and debate issues.
Ability to quickly assimilate facts and data and develop an understanding of complex matters.
Strong analytical skills with drive to synthesize the story into an actionable set of recommendations
Assesses needs & constraints and converts these into a realistic solution
Is resourceful on innovation opportunities in the area of expertise
Project management and change management
#GSK-LI
Skills
Artificial Intelligence (AI), Business Analysis, Data Analysis, Data Mining, Digital Fluency, Organization Transformation, Product Development, Project Management, Security System Design• If you are based in Cambridge, MA; Waltham, MA; Rockville, MD; or San Francisco, CA, the annual base salary for new hires in this position ranges $119,625 to $199,375. The US salary ranges take into account a number of factors including work location within the US market, the candidate’s skills, experience, education level and the market rate for the role. In addition, this position offers an annual bonus and eligibility to participate in our share based long term incentive program which is dependent on the level of the role. Available benefits include health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and paid caregiver/parental and medical leave. If salary ranges are not displayed in the job posting for a specific country, the relevant compensation will be discussed during the recruitment process.
Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.
Why GSK?
Uniting science, technology and talent to get ahead of disease together.
GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.
People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.
If you require an accommodation or other assistance to apply for a job at GSK, please contact the appropriate Recruitment Staff by emailing us at - usrecruitment.adjustments@gsk.com
GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.
Important notice to Employment businesses/ Agencies
GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.
Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK’s compliance to all federal and state US Transparency requirements. For more information, please visit the Centers for Medicare and Medicaid Services (CMS) website at https://openpaymentsdata.cms.gov/
Related keywords
Lab Systems ManagerR&DNetwork IntegrationCyber SecurityData IntegrityComputer System ValidationCAPEXOT SecurityGxPLife Cycle ManagementAutomationAnalytical SoftwareGAMPCFR 21Change ManagementProject Management
We are uniting science, technology and talent to get ahead of disease together.
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Offices: 79 New Oxford Street, London, England WC1A 1DG, GB · 5 Crescent Drive, Philadelphia, Pennsylvania PA 19112, US · Gunnels Wood Road, Stevenage, England SG1 2, GB · 9 Canton Rd, 23/F, Tower 6, The Gateway, Kowloon, Hong Kong ., HK · Bogota Corporate Center Av. Eldorado No. 69B – 45 / 9th Floor Bogotá, D.C., Bogota, Bogota, D.C. 110931, CO
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How many Security & Safety jobs are open in Cambridge, MA right now?
There are currently 272 open security & safety positions in Cambridge, MA listed on Clera. New openings are added daily as companies post roles.
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Companies currently hiring include Akamai Technologies, Draper, MORSE Corp, Harvard Division of Medical Sciences, Veolia | France, among others. Browse the listings above to see every active employer.
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