{bc}
Apply
workday

Sr Process Engineer

GSK
USA
Full-time
Senior · 5+ years experience
Onsite
Discovered 3 weeks ago
Communication

Full Job Posting

Preferred Qualifications:

  • Must have demonstrated self-direct work habits along with verbal and written communication skills. · Must be a committed team player prepared to work in and embrace a team-based culture.
  • Familiarity with regulatory expectations regarding electronic records and electronic signatures. Able to maintain attention to detail while executing multiple with minimal supervision. Must operate cross-functionally and be able to lead in a matrix organization. Strong understanding of Good Manufacturing Practices (GMP) related to drug substance processes.
  • Experience with process flow design and process optimization techniques. Ability to analyze data and use results to make clear, actionable recommendations. Good communication skills and a collaborative mindset. Experience in process validation, risk assessment, and change management.
  • Proven skills in documentation for compliance and regulatory audits. Leadership experience or ability to influence cross-functional teams. Experience preparing and delivering presentations and technical reports. Familiarity with regulatory inspection processes in pharmaceutical manufacturing.
  • If you want to be part of a team where your work makes a real difference in patients’ lives, we encourage you to apply. Share your story and tell us how your background and passion can help us improve medicines for billions around the world. We look forward to hearing from you.
  • Must have demonstrated self-direct work habits along with verbal and written communication skills. Must be a committed team player prepared to work in and embrace a team-based culture. Familiarity with regulatory expectations regarding electronic records and electronic signatures. Able to maintain attention to detail while executing multiple tasks. Able to perform job duties with minimal supervision. Must operate cross-functionally and be able to lead in a matrix organization.
  • #LI-GSK
  • #GSKCareers
  • Proven skills in documentation for compliance and regulatory audits.
  • Leadership experience or ability to influence cross-functional teams.
  • Experience preparing and delivering presentations and technical reports. Familiarity with regulatory inspection processes in pharmaceutical manufacturing.

Skills

  • Asset Life Cycle Management, Data Integrity, Digital Fluency, GxP Regulations, Lean Management, Manufacturing Technologies, Pharmaceutical Manufacturing, Problem Solving, Risk Awareness, Standards Compliance
  • 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 - [email protected]
  • 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/

Qualifications

  • Bachelor’s degree in engineering for a scientific field. A bachelor's is minimally required, and an absolute requirement for this role.
  • Minimum of 5 + years of experience in process engineering within pharmaceutical or medical device manufacturing.
  • Experience with Good Manufacturing Practices, Pharma or Vaccine formulation and filling facilities. Experience and strong knowledge with Aseptic Bio Pharms operations, equipment and facility design and operation. Experience with process flow design and process optimization techniques. Ability to analyze data and use results to make clear, actionable recommendations.
  • Technical understanding of the pharmaceutical industry and engineering practices. Demonstrated the ability to generate options to resolve problems, prioritize solutions, determine appropriate course of action, gain consensus on that recommendation, and implement decisions. ·
  • Asset Life Cycle Management, Data Integrity, Digital Fluency, GxP Regulations, Lean Management, Manufacturing Technologies, Pharmaceutical Manufacturing, Problem Solving, Risk Awareness, Standards Compliance
  • 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 - [email protected]
  • 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/

Responsibilities

  • This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:
  • Lead the design, specification, procurement, installation, commissioning, validation, and continued technical support of in bioprocess equipment and facility design / operation including buffer preparation, small batch reactors, UFDF, formulation, filling, manufacturing support (COPSOP, Part Washer, Autoclave).
  • Facilitate multi-disciplined teams in the performance of HAZOPs, FMEAs, process reviews and SOP development efforts. Lead or assist with development of local standards and guidelines. Author, revise and review SOPs as required. Perform process monitoring to verify process throughput, consistency and compliance with GSK Bio and industry accepted best practices. Initiate and execute process improvement projects to address process deficiencies or to improve process throughput. Facilitate efforts to define and make decisions on site standards for process equipment and process instruments.
  • Act as a primary interface with outside engineering consulting firms on process design projects, process design issues, interpretation of Owner project requirements, Code compliance, equipment selection, value engineering, construction and implementation.
  • Manage vendors, consultants and contractors to ensure that process and project design and installation including FAT and SAT is in compliance with cGMP requirements & GSK Bio standards and that contracts contain appropriate technical specifications and are delivered as required.
  • Stay current with technical developments in the field of vaccine formulation and manufacturing equipment design, equipment, control technology and GSK-Bio Standards. Evaluate new technologies and provide technical solutions to solve process problems and to improve process efficiency and throughput.
  • Ensure all validation, quality, engineering, safety, and environmental procedures and regulations are met, maintained and documented appropriately. Perform or oversee the execution of equipment and/or process simulations in order to appropriately size equipment and systems for their intended service. Participate in site Operational Excellence initiatives. Perform Benchmarking with other GSK sites to incorporate Best Practices. Will support commissioning and validation efforts of site systems including protocol generations (CTP, IO/OQ, Engineering Studies), change control initiations, CAPA development and implementation, deviation investigations, and support operations Performance Qualification efforts During audits, provide technical expertise for site systems where appropriate.
  • Participate in Technology Transfer efforts and Functional Forums as needed to ensure that appropriate process equipment and clean utility systems are in the correct configuration to successfully implement new or revised manufacturing processes. Ensure application of GSK standards and Guidelines for all projects and participate in the development and updating of local Policies and Procedures.

Apply for this job in 1 click

Skip the repetitive application forms

Install the Base Career Chrome Extension and autofill job applications across major job boards with your profile.

Sarah M.James T.Maya R.

Trusted by over 500,000 job seekers on Base Career

Start Free Today

More from this employer

More jobs at GSK

Lead Analyst, Design Assurance & Product Management - Application Security

Bengaluru, IND

Discovered TodayFull-time

Principal - AI ML and Cloud Security

Bengaluru, IND

Discovered TodayFull-time

Senior Principal - Design Assurance & Product Management - Independent Design Assurance

Bengaluru, IND

Discovered TodayFull-time

Director - Security Architecture & Solution Engineering - OT Security

Bengaluru, IND

Discovered TodayFull-time

Medical Representative - Jeddah

Jeddah, KSA

Discovered TodayFull-time

Senior Principal - Design Assurance & Product Management - Security Products

Bengaluru, IND

Discovered TodayFull-time

Senior Principal Architect - Security Architecture & Solution Engineering - OT Security

Bengaluru, IND

Discovered TodayFull-time

Medical Representative - Jeddah

Jeddah, KSA

Discovered TodayFull-time