Associate Technician Operations Night Shift

Job description

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, 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 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 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: 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 This position will initially be Sun-Thur, Night shift. (10 PM - 6:30 AM) Successful completion of TB titer and Chest X-ray are required. Preferred Experience and Skills (General): Minimum Associates Degree in science or related field BioWork 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 The following experience is a significant advantage for an Associate Technician supporting Process Support operations: Aseptic Behaviors Aseptic Techniques & Manipulations cRAB/Isolator Experience Environmental Monitoring #MSJR The salary range for this role is: $43,100 - $67,800 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. #MSJR #EBRG's Required Skills: Business Process Automation, Business Process Automation, Business Process Management (BPM), Chemical Plant Operations, Cleanroom Gowning, CNC Operations, Computer Literacy, Conventional Machining, Drilling Machines, Driving Continuous Improvement, Enterprise Resource Planning (ERP), Equipment Set Up, Global Manufacturing, Manufacturing, Manufacturing Compliance, Material Selection, Oral Communications, Process Improvements, Production Scheduling, Quality Monitoring, Raw Materials, Safety Procedures, SAP PP (Production Planning), Shift Work, TB Testing {+ 1 more} Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE 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. 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 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 Search 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 agen