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GMP Operations Specialist

3 months ago

Richmond, United States Haleon Full time

Hello. We’re Haleon. A new world-leading consumer health company. Shaped by all who join us. Together, we’re improving everyday health for billions of people. By growing and innovating our global portfolio of category-leading brands – including Sensodyne, Advil, Voltaren, Theraflu, and Centrum – through a unique combination of deep human understanding and trusted science. What’s more, we’re achieving it in a company that we’re in control of. In an environment that we’re co-creating. And a culture that’s uniquely ours. Care to join us. It isn’t a question. 

 

The GMP Operations Specialist is an expert who provides operational support to technical project teams including Richmond Pilot plant and Global Scale Up. Responsibilities range from general material handling, equipment assembly, operation, cleaning, maintenance, and creation and execution of batch records and protocols to support for IQ/OQ/PQ activities and cleaning validation. 

 

The GMP Operations Specialist works in close collaboration with the Pilot Plant Lead and the extended team to execute project related scale up activities. Depending on level of experience the individual would help support and oversee qualification protocols related to process and cleaning.  

 

Role Responsibilities  

  • Prepares and executes life cycle activities for equipment and systems within the GMP pilot plant (specification, purchase, IQ/OQ/PQ, etc.) 

  • Coordinates equipment training activities for operators and scientist in the pilot plant  

  • Provides technical leadership and support to project teams during manufacture of product within the pilot plant 

  • Provides technical support and troubleshooting assistance for all equipment and systems within the pilot plant 

  • Interfaces with external vendors and service providers to arrange equipment demonstrations, troubleshooting, and repairs 

  • Ensures all work is conducted in accordance with written procedures (i.e. quality, safety, methods, batch documents, etc) 

  • Identifies, challenges, develops, and implements written procedures 

  • Supports safety and quality responsibilities for department and site (i.e. GMP, Audits, Health & Safety) 

  • Delivers all EHS standards and expectations on site and within the pilot plant, including development of suitable risk assessments for pilot plant equipment and activities 

 

GROWTH MINDSET 

  • Highlights own training needs and, working with PPL, develops a training plan and achieves training goals 

  • Trains self and other in new technology and laboratory responsibilities. 

  • Develops knowledge of regulations impacting areas of work (e.g. EP/USP/ICH, FDA, DEA, OSHA). 

  • Builds relationships with cross-functional partners to deliver shared goals. 

 

DATA-DRIVEN 

  • Ensures all work is always conducted following cGDPs and cGXPs. 

 

AGILE 

  • Takes responsibility for specific equipment in accordance to site procedure. 

  • Participates and may lead in general problem solving or leads specific problem solving initiatives. 

 

 

Why you? 

Basic Qualifications: 

  • BS or Technical degree in Pharmaceutical, Engineering or related science 

  • Minimum 5 years prior experience in the pharmaceutical or consumer health industry, specifically in pilot plants, validation, or engineering. 

  • Experience in a GMP regulated environment. 

  • The ideal candidate would have experience in manufacturing semi-solid and/or liquid forms, and experience within Operational Excellence and Lean Six Sigma tools.  

  • Candidate has demonstrable experience taking initiative, thinking and working independently, problem-solving and working in teams. 

 

Location: This role is hybrid based in Richmond, VA 

This job posting closes on June 30, 2024 

 

Haleon offers a robust Total Reward package that consists of competitive pay and a comprehensive benefits program.  This includes a generous 401(k) plan, tuition reimbursement and time off programs including 6 months paid parental leave.  On day one, you are eligible for benefits, including our healthcare programs where the company pays for the majority of your medical coverage for you and your family.  We also offer the opportunity to receive a discretionary bonus based on the achievement of key business performance and other incentive/recognition programs as part of the offering. 

 

#Li-Hybrid 

 

 

Care to join us. Find out what life at Haleon is really like www.haleon.com/careers/

At Haleon we embrace our diverse workforce by creating an inclusive environment that celebrates our unique perspectives, generates curiosity to create unmatched understanding of each other, and promotes fair and equitable outcomes for everyone. We're striving to create a climate where we celebrate our diversity in all forms by treating each other with respect, listening to different viewpoints, supporting our communities, and creating a workplace where your authentic self belongs and thrives. We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.

As you apply, we will ask you to share some personal information, which is entirely voluntary. We want to have an opportunity to consider a diverse pool of qualified candidates and this information will assist us in meeting that objective and in understanding how well we are doing against our inclusion and diversity ambitions. We would really appreciate it if you could take a few moments to complete it. Rest assured, Hiring Managers do not have access to this information and we will treat your information confidentially.

Haleon is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.

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, Haleon may be required to capture and report expenses Haleon 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 Haleon’s compliance to all federal and state US Transparency requirements.