Technician, Operations

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 youll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.

Responsibilities may include but are not limited to:

Project Support

• Supports Team through Aseptic Process Sim & Process Performance Qualifications.

• 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 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

• The position will be Mon-Fri Day Shift (6am-2:30pm). Overtime required upon request.

• Successful completion of TB titer and Chest X-ray are required.

Preferred Experience and Skills (General):

• 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 GLIMS 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

The following experience is a significant advantage for a Technician supporting Drug Substance operations:

• Aseptic Behaviors

• Aseptic Techniques & Manipulations

• Closed Restricted Access Barrier System (cRAB)/Isolator

• Environmental Monitoring

• Autoclaves #SHPE2025 #MSJR #EBRG VetJobs

Required Skills:

Preferred Skills:

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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.

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 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:

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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 anothers thinking and approach problems collectively.

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U.S. 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 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.

San Francisco Residents Only:We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only:We will consider for employment all qualified applicants including those with criminal histories in a manner consistent with the requirements of applicable state and local laws including the City of Los Angeles Fair Chance Initiative for Hiring Ordinance

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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.

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Relocation:

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