Associate Specialist, Purification Technical Engineering (Hybrid)
Job DescriptionDescription Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products.
The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where our companyt has codified its legacy for over a century.
Our company's success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.
The Maurice R.
Hilleman Center for Vaccine Manufacturing is located in Durham, NC.
This state-of-the-art facility established in 2004, manufactures our lifesaving vaccines in bulk and finished forms.
Due to the importance of this facility in our Vaccine Manufacturing network, the facility has seen rapid growth in production volumes and new employees over the last several years; currently Durham employs 1,000
people.
Durham's Technology Transfer Associate Specialist will be an energetic, technical leader with strong interpersonal, communication, and collaboration skills responsible for implementation of technology transfer process knowledge, post approval support, and post commercial process enhancement activities for pipeline vaccine programs.
This position will primarily support the downstream purification process for the technology transfer of our HPV vaccine drug substance.
Additionally, this role will contribute to the performance and results of a department, provide technical guidance, and anticipate and interpret client and/or customer needs to identify and implement solutions.
Off-shift and weekend coverage will be required based on business unit needs and specific assignments.
The role encompasses technical services support in the areas of equipment and automation systems, validation, deviation management and product franchise.
Specific assignments may be focused in one area or span across multiple areas of focus.
Responsibilities may include but are not limited to; Provide downstream purification technical/team support for commercial technology transfer, and qualification studies associated with the development and implementation of processes, systems and facilities related to vaccine drug substance and key intermediates Actively participate on cross-functional manufacturing teams to advance project goals and deliverables related to the vaccine process Support technical studies and author documentation associated with site commercialization efforts Provide SME knowledge for manufacturing investigations support (Product and process deviations and complex material-related events) Collaborate with internal/external partners, e.
g.
Other sites, Global Teams, Procurement, Raw Material & Component Suppliers Author, review, and/or edit technical documents to support regulatory filings including technical protocols, reports, and risk assessments Support aspects of regulatory inspections by presenting and defending technical documentation, investigations, and change controls Evaluate and develop innovative process technologies, continuous process improvements and post launch process enhancements Provide post approval support and subject matter expertise support to ongoing manufacturing activities.
Qualifications Education Minimum Requirement:
Bachelor of Science Degree in Chemical Engineering, Biochemical Engineering, Bioengineering, or related life science field.
Required Experience and Skills:
Demonstrated written and verbal communications skills Demonstrated systematic problem-solving skills Ability to foster a collaborative work environment Preferred Experience and Skills:
Experience in vaccine or biologics manufacturing within a cGMP environment Experience authoring technical documentation (technical investigations, protocols, reports, or change controls) within a cGMP context.
Experience with on-the-floor cGMP manufacturing support including providing immediate responses on the shop floor to deviations and supply chain interruptions Ability to read Piping and Instrumentation Diagrams is desired Experience with process risk assessment tools Lean Six Sigma belt certification Travel:
10% of the timeNOTICE FOR INTERNAL APPLICANTSIn accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.
If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package.
To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.
#VETJOBS #EBRGEmployees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders).
Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated.
Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.
Current Employees apply HERECurrent Contingent Workers apply HEREUS and Puerto Rico Residents Only:
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities.
Please click here if you need an accommodation during the application or hiring process.
For more information about personal rights under Equal Employment Opportunity, visit:
EEOC Know Your RightsEEOC GINA SupplementPay Transparency NondiscriminationWe are proud to be a company that embraces the value of bringing diverse, talented, and committed people together.
The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment.
We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.
We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.
U.
S.
Hybrid Work ModelEffective September 5,2023 our U.
S.
Hybrid work model will be as follows:
1.
Three total days on site per week:
Tuesday and Wednesday - plus one additional day of choice based on what works best for organizations and/or teams.
2.
Fridays will formally be a remote-working day unless business critical tasks require onsite presence.
Learn more about your rights, including under California, Colorado and other US State ActsSearch Firm Representatives Please Read Carefully Merck & Co.
, Inc.
, Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities.
All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.
No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place.
Where agency agreements are in place, introductions are position specific.
Please, no phone calls or emails.
Employee Status:
RegularRelocation:
DomesticVISA Sponsorship:
NoTravel Requirements:
10%Flexible Work Arrangements:
HybridShift:
1st - DayValid Driving License:
NoHazardous Material(s):
None Recommended Skills Automation Biology Biopharmaceuticals Cvs Chemical Engineering Communication Estimated Salary: $20 to $28 per hour based on qualifications.
The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where our companyt has codified its legacy for over a century.
Our company's success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.
The Maurice R.
Hilleman Center for Vaccine Manufacturing is located in Durham, NC.
This state-of-the-art facility established in 2004, manufactures our lifesaving vaccines in bulk and finished forms.
Due to the importance of this facility in our Vaccine Manufacturing network, the facility has seen rapid growth in production volumes and new employees over the last several years; currently Durham employs 1,000
people.
Durham's Technology Transfer Associate Specialist will be an energetic, technical leader with strong interpersonal, communication, and collaboration skills responsible for implementation of technology transfer process knowledge, post approval support, and post commercial process enhancement activities for pipeline vaccine programs.
This position will primarily support the downstream purification process for the technology transfer of our HPV vaccine drug substance.
Additionally, this role will contribute to the performance and results of a department, provide technical guidance, and anticipate and interpret client and/or customer needs to identify and implement solutions.
Off-shift and weekend coverage will be required based on business unit needs and specific assignments.
The role encompasses technical services support in the areas of equipment and automation systems, validation, deviation management and product franchise.
Specific assignments may be focused in one area or span across multiple areas of focus.
Responsibilities may include but are not limited to; Provide downstream purification technical/team support for commercial technology transfer, and qualification studies associated with the development and implementation of processes, systems and facilities related to vaccine drug substance and key intermediates Actively participate on cross-functional manufacturing teams to advance project goals and deliverables related to the vaccine process Support technical studies and author documentation associated with site commercialization efforts Provide SME knowledge for manufacturing investigations support (Product and process deviations and complex material-related events) Collaborate with internal/external partners, e.
g.
Other sites, Global Teams, Procurement, Raw Material & Component Suppliers Author, review, and/or edit technical documents to support regulatory filings including technical protocols, reports, and risk assessments Support aspects of regulatory inspections by presenting and defending technical documentation, investigations, and change controls Evaluate and develop innovative process technologies, continuous process improvements and post launch process enhancements Provide post approval support and subject matter expertise support to ongoing manufacturing activities.
Qualifications Education Minimum Requirement:
Bachelor of Science Degree in Chemical Engineering, Biochemical Engineering, Bioengineering, or related life science field.
Required Experience and Skills:
Demonstrated written and verbal communications skills Demonstrated systematic problem-solving skills Ability to foster a collaborative work environment Preferred Experience and Skills:
Experience in vaccine or biologics manufacturing within a cGMP environment Experience authoring technical documentation (technical investigations, protocols, reports, or change controls) within a cGMP context.
Experience with on-the-floor cGMP manufacturing support including providing immediate responses on the shop floor to deviations and supply chain interruptions Ability to read Piping and Instrumentation Diagrams is desired Experience with process risk assessment tools Lean Six Sigma belt certification Travel:
10% of the timeNOTICE FOR INTERNAL APPLICANTSIn accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.
If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package.
To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.
#VETJOBS #EBRGEmployees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders).
Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated.
Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.
Current Employees apply HERECurrent Contingent Workers apply HEREUS and Puerto Rico Residents Only:
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities.
Please click here if you need an accommodation during the application or hiring process.
For more information about personal rights under Equal Employment Opportunity, visit:
EEOC Know Your RightsEEOC GINA SupplementPay Transparency NondiscriminationWe are proud to be a company that embraces the value of bringing diverse, talented, and committed people together.
The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment.
We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.
We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.
U.
S.
Hybrid Work ModelEffective September 5,2023 our U.
S.
Hybrid work model will be as follows:
1.
Three total days on site per week:
Tuesday and Wednesday - plus one additional day of choice based on what works best for organizations and/or teams.
2.
Fridays will formally be a remote-working day unless business critical tasks require onsite presence.
Learn more about your rights, including under California, Colorado and other US State ActsSearch Firm Representatives Please Read Carefully Merck & Co.
, Inc.
, Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities.
All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.
No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place.
Where agency agreements are in place, introductions are position specific.
Please, no phone calls or emails.
Employee Status:
RegularRelocation:
DomesticVISA Sponsorship:
NoTravel Requirements:
10%Flexible Work Arrangements:
HybridShift:
1st - DayValid Driving License:
NoHazardous Material(s):
None Recommended Skills Automation Biology Biopharmaceuticals Cvs Chemical Engineering Communication Estimated Salary: $20 to $28 per hour based on qualifications.
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