MSD
Manufacturing Operations Technician Durham, NC Old Oxford
MSD, Durham, North Carolina, United States, 27703
Job Description
Our Manufacturing Operations teams are the people that make therapies for our patients. We work in the manufacturing plants with a “Safety First, Quality Always” mindset, striving for continuous improvement, and earn our right to produce. We work in local plants connected to our global manufacturing network supplying the highest quality of raw materials, intermediates, and finished products.
This 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.
Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity, and teamwork of people like you. To this end, we strive to create an environment of mutual respect, encouragement, and teamwork. As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.
Responsibilities
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 Expertise:
Competent 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.
Education Minimum Requirement
High School Diploma/GED or higher.
Required Experience and Skills
At least one (1) year GMP manufacturing/processing experience.
Demonstrated written and verbal communication 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.
The position will initially be Mon-Fri, day shift. Must be willing to work various shift schedules as required when operations start.
Successful completion of TB titer and Chest X‑ray are required.
Preferred Experience and Skills (General)
Minimum associate's degree in science or related field.
Bio‑Work 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‑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.
Preferred Experience for Drug Product Technician
Aseptic filling operations.
Grade A isolator containment systems.
Lyophilization.
Visual inspection of product in glass vials including manual & automated techniques.
Experience with autoclaves, washers, and dry heat ovens.
Travel Up to 5% of the time.
Required Skills
Accountability
Analytical Problem Solving
Biological Manufacturing
Biotechnology
Cleanroom Gowning
Computer Literacy
Digital Literacy
Driving Continuous Improvement
Freeze Drying
Global Manufacturing
GMP Compliance
GMP Operations
Good Manufacturing Practices (GMP)
Healthcare Innovation
Laboratory Processes
Machinery Operation
Manufacturing
Manufacturing Quality Control
Microbiological Cultures
Operations Consulting
Packaging Operations
Pharmaceutical Manufacturing
Production Scheduling
Project Management
Preferred Skills
Current Employees apply (information removed)
US 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.
Equal Employment Opportunity As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
EEOC Know Your Rights
EEOC GINA Supplement
We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.
Learn more about your rights, including under California, Colorado and other US State Acts
Hybrid Work Model Effective September 5, 2023, employees in office‑based positions in the U.S. will be working a Hybrid work consisting of three total days on‑site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote‑working day, unless business critical tasks require an on‑site presence. This Hybrid work model does not apply to, and daily in‑person attendance is required for, field‑based positions; facility‑based, manufacturing‑based, or research‑based positions where the work to be performed is located at a Company site; positions covered by a collective‑bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.
Job Posting Information Job Posting End Date: 01/9/2026
#J-18808-Ljbffr
This 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.
Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity, and teamwork of people like you. To this end, we strive to create an environment of mutual respect, encouragement, and teamwork. As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.
Responsibilities
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 Expertise:
Competent 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.
Education Minimum Requirement
High School Diploma/GED or higher.
Required Experience and Skills
At least one (1) year GMP manufacturing/processing experience.
Demonstrated written and verbal communication 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.
The position will initially be Mon-Fri, day shift. Must be willing to work various shift schedules as required when operations start.
Successful completion of TB titer and Chest X‑ray are required.
Preferred Experience and Skills (General)
Minimum associate's degree in science or related field.
Bio‑Work 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‑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.
Preferred Experience for Drug Product Technician
Aseptic filling operations.
Grade A isolator containment systems.
Lyophilization.
Visual inspection of product in glass vials including manual & automated techniques.
Experience with autoclaves, washers, and dry heat ovens.
Travel Up to 5% of the time.
Required Skills
Accountability
Analytical Problem Solving
Biological Manufacturing
Biotechnology
Cleanroom Gowning
Computer Literacy
Digital Literacy
Driving Continuous Improvement
Freeze Drying
Global Manufacturing
GMP Compliance
GMP Operations
Good Manufacturing Practices (GMP)
Healthcare Innovation
Laboratory Processes
Machinery Operation
Manufacturing
Manufacturing Quality Control
Microbiological Cultures
Operations Consulting
Packaging Operations
Pharmaceutical Manufacturing
Production Scheduling
Project Management
Preferred Skills
Current Employees apply (information removed)
US 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.
Equal Employment Opportunity As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
EEOC Know Your Rights
EEOC GINA Supplement
We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.
Learn more about your rights, including under California, Colorado and other US State Acts
Hybrid Work Model Effective September 5, 2023, employees in office‑based positions in the U.S. will be working a Hybrid work consisting of three total days on‑site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote‑working day, unless business critical tasks require an on‑site presence. This Hybrid work model does not apply to, and daily in‑person attendance is required for, field‑based positions; facility‑based, manufacturing‑based, or research‑based positions where the work to be performed is located at a Company site; positions covered by a collective‑bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.
Job Posting Information Job Posting End Date: 01/9/2026
#J-18808-Ljbffr