Senior Technician, Operations - USA - North Carolina - Durham (Old Oxford)
Job DescriptionThis role is within a capital project start-up in Durham, North Carolina.
The new facility will include end-to-end processing of drug substance, drug product, including biotech culture growth, harvest, lyophilization, product inspection, utilities, and warehouse.
As the team finishes design and construction of the facility, the Senior Technician will play a critical role in supporting the Global Engineering Services team, partnering with internal stakeholders, and building the operations team who will take ownership of the facility.
Members of the Operations team in this new and exciting facility will have the unique opportunity to give input in the design process, startup their areas, and lead the teams to full production.
The following experience is a significant advantage for a Senior Technician supporting Drug Substance operations:
Aseptic Behaviors Aseptic Techniques & Manipulations cRAB/Isolator Experience Pipetting Environmental Monitoring The position will initially be Mon-Fri, day shift and will transition to second shift when Operations start in late Q3/Q4.
This position is for second shift, Mon-Fri.
Responsibilities may include but are not limited to:
Project Support Supports project team as operations expert through start-up, commissioning, qualification through licensure and ramp up of facility.
Author, review, and/or edit operations and technical documentation (Batch Records, SOPs, Job Aides, training, and engineering documents) to support project and future operations.
Identifies and addresses compliance, environmental, safety, and process deviations as appropriate while coordinating with appropriate personnel.
Actively participate in team meetings HAZOPS, waste walkthroughs, 5S, kaizen events, or any other operations, lean six-sigma, quality, safety or environmental training/initiatives as required.
Operational ExpertiseCompetent execution and ownership to meet production targets for area within responsibility including:
Attending and escalation of concerns or needs at daily huddles and as needed Cleaning, setup, operation and troubleshooting of equipment and facilities Maintenance and transportation of consumable and material inventories Maintenance of excellent recordkeeping and housekeeping Drives culture of continuous improvement.
Implements and raises ideas to increase success of group Participates on and/or performs activities to support technical and OPEX functions such as Kaizen events, ad-hoc sampling, or protocol execution.
Maintains detailed knowledge of equipment and processes.
Identifies and addresses compliance, environmental, safety, and process deviations as appropriate while notifying appropriate personnel.
Position
Qualifications:
Education Minimum Requirement:
High School Diploma/GED or higherRequired Experience and Skills:
At least two (2) years GMP manufacturing/processing experience, or a Bachelor's degree in Life Science or Engineering Demonstrated written and verbal communications skills Must be able to successfully pass and maintain aseptic gowning qualifications.
Aseptic gowning requires that all skin and hair be covered through wearing the following:
beard/mustache cover, hair net, hood and facemask, goggles, jumpsuit, gloves, and boots.
Computer literacy (internet browsers, e-mail, spreadsheets, word processing) Must be willing and able to lift 50 lbs, bend, stoop, squat, crawl, twist, climb ladders, and wear a respirator Successful completion of TB titer and Chest X-ray are required.
Preferred Experience and Skills:
Minimum Associates Degree in science or related field Bioworks Certificate (working in an FDA or similar regulated industry) Applicable mechanical and project management experience Experience with automated systems (MES, SAP, DeltaV, or similar) Experience with on-the-floor cGMP manufacturing and familiarity with regulatory requirements and Good Documentation Practices (GDP) Demonstrated ability to work both independently and as a part of a team NOTICE 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.
Employees 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:
No relocationVISA Sponsorship:
NoTravel Requirements:
No Travel RequiredFlexible Work Arrangements:
On-SiteShift:
Not IndicatedValid Driving License:
NoHazardous Material(s):
n/a Recommended Skills Automation Biology Biotechnology Business Process Improvement Cvs Communication Estimated Salary: $20 to $28 per hour based on qualifications.
The new facility will include end-to-end processing of drug substance, drug product, including biotech culture growth, harvest, lyophilization, product inspection, utilities, and warehouse.
As the team finishes design and construction of the facility, the Senior Technician will play a critical role in supporting the Global Engineering Services team, partnering with internal stakeholders, and building the operations team who will take ownership of the facility.
Members of the Operations team in this new and exciting facility will have the unique opportunity to give input in the design process, startup their areas, and lead the teams to full production.
The following experience is a significant advantage for a Senior Technician supporting Drug Substance operations:
Aseptic Behaviors Aseptic Techniques & Manipulations cRAB/Isolator Experience Pipetting Environmental Monitoring The position will initially be Mon-Fri, day shift and will transition to second shift when Operations start in late Q3/Q4.
This position is for second shift, Mon-Fri.
Responsibilities may include but are not limited to:
Project Support Supports project team as operations expert through start-up, commissioning, qualification through licensure and ramp up of facility.
Author, review, and/or edit operations and technical documentation (Batch Records, SOPs, Job Aides, training, and engineering documents) to support project and future operations.
Identifies and addresses compliance, environmental, safety, and process deviations as appropriate while coordinating with appropriate personnel.
Actively participate in team meetings HAZOPS, waste walkthroughs, 5S, kaizen events, or any other operations, lean six-sigma, quality, safety or environmental training/initiatives as required.
Operational ExpertiseCompetent execution and ownership to meet production targets for area within responsibility including:
Attending and escalation of concerns or needs at daily huddles and as needed Cleaning, setup, operation and troubleshooting of equipment and facilities Maintenance and transportation of consumable and material inventories Maintenance of excellent recordkeeping and housekeeping Drives culture of continuous improvement.
Implements and raises ideas to increase success of group Participates on and/or performs activities to support technical and OPEX functions such as Kaizen events, ad-hoc sampling, or protocol execution.
Maintains detailed knowledge of equipment and processes.
Identifies and addresses compliance, environmental, safety, and process deviations as appropriate while notifying appropriate personnel.
Position
Qualifications:
Education Minimum Requirement:
High School Diploma/GED or higherRequired Experience and Skills:
At least two (2) years GMP manufacturing/processing experience, or a Bachelor's degree in Life Science or Engineering Demonstrated written and verbal communications skills Must be able to successfully pass and maintain aseptic gowning qualifications.
Aseptic gowning requires that all skin and hair be covered through wearing the following:
beard/mustache cover, hair net, hood and facemask, goggles, jumpsuit, gloves, and boots.
Computer literacy (internet browsers, e-mail, spreadsheets, word processing) Must be willing and able to lift 50 lbs, bend, stoop, squat, crawl, twist, climb ladders, and wear a respirator Successful completion of TB titer and Chest X-ray are required.
Preferred Experience and Skills:
Minimum Associates Degree in science or related field Bioworks Certificate (working in an FDA or similar regulated industry) Applicable mechanical and project management experience Experience with automated systems (MES, SAP, DeltaV, or similar) Experience with on-the-floor cGMP manufacturing and familiarity with regulatory requirements and Good Documentation Practices (GDP) Demonstrated ability to work both independently and as a part of a team NOTICE 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.
Employees 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:
No relocationVISA Sponsorship:
NoTravel Requirements:
No Travel RequiredFlexible Work Arrangements:
On-SiteShift:
Not IndicatedValid Driving License:
NoHazardous Material(s):
n/a Recommended Skills Automation Biology Biotechnology Business Process Improvement Cvs Communication Estimated Salary: $20 to $28 per hour based on qualifications.
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