Menu

Senior Technician, Operations

at Merck in Dover, Delaware, United States

Job Description

Job Description

Job Description

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. 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.

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 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

Required Experience and Skills:

+ High school/GED and at least five (5) years GMP manufacturing/processing experience

+ Associate’s Degree and at least three (3) years GMP manufacturing/processing experience

+ Bachelor’s Degree and at least two (2) years of 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 booties.

+ 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 is for First Shift (Monday-Friday), 6am-2:30pm, Steady State Production. A flexible shift 1A (7am – 3:30pm) will be worked until late Q3/Q4 2024 to support Start Up Activities.

+ 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 a Senior Technician supporting Drug Substance operations:

+ Aseptic Behaviors

+ Aseptic Techniques & Manipulations

+ cRAB/Isolator Experience

+ Material Movements (SAP)

+ MES

+ Aseptic Gowning (Grade B)

+ Pipetting

NOTICE FOR INTERNAL APPLICANTS

In 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 #EBRG MSJR TechnicianDurham

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 HERE (https://wd5.myworkday.com/msd/d/task/1422$6687.htmld)

Current Contingent Workers apply HERE (https://wd5.myworkday.com/msd/d/task/1422$4020.htmld)

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 (https://survey.sogosurvey.com/r/aCdfqL) if you need an accommodation during the application or hiring process.

We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

EEOC Know Your Rights (https://www.eeoc.gov/sites/default/files/2022-10/22-088\EEOC\KnowYourRights\10\20.pdf)

EEOC GINA Supplement?

Pay Transparency Nondiscrimination (https://www.dol.gov/sites/dolgov/files/OFCCP/pdf/pay-transp\%20English\formattedESQA508c.pdf)

We are proud to be a company that embraces the value of bringing diverse, talen

Copy Link

Job Posting: JC259856954

Posted On: May 15, 2024

Updated On: Jun 02, 2024

Please Wait ...