Equipment Operation Engineer

Job Description

The Formulation, Laboratory, and Experimentation (FLEx) Center is a new multi-modality (small molecule, biologics, vaccine) Drug Product development and Good Manufacturing Practice (GMP) clinical manufacturing plant in Rahway, New Jersey. The Sterile Operations Equipment Operation Engineer will serve as a primary operations specialist within in the FLEx Sterile GMP Clinical Manufacturing facility.

To enable our Company’s ever evolving pipeline the new FLEx Sterile facility will be equipped with leading edge robotic isolators and novel technologies. These technologies will enable speed and flexibility driving drug products from concepts to clinical supplies for our patients. As the facility is currently under construction, the selected candidate will apply her/his relevant experience to contribute to equipment and facility design, system commissioning/qualification, regulatory certification, as well as other workstreams’ critical activities to enable facility startup and operational readiness.

When operations commence, this individual will partner closely with the formulators, engineers, Quality representatives, and other team members to ensure the quality of the clinical supplies, the scientific rigor of the processes, and ultimately to enable flexibility and speed of our Company's sterile pipeline. The role is based in New Jersey and reports to the Sterile Production Lead of the FLEx GMP facility within Pharmaceutical Operations and Clinical Supply.

Once the facility is operational, duties will include but are not limited to the following:

• Work with a variety of state of the art and robotic manufacturing equipment while completing processes throughout the manufacturing cycle

• Manage individual project assignments and aid in facility and process equipment innovation.

• Perform manual and/or automated operations, general maintenance, troubleshooting and support functions

• Perform aseptic manipulations within Grade A barrier isolation systems

• Contemporaneous record keeping including equipment and area cleaning and use logs, and all pertinent batch and/or equipment preparation documentation.

• Identify and addresses compliance, environmental, safety, and process deviations as appropriate while notifying appropriate personnel

• Demonstrate, at all times, safe work habits and maintain a safe work environment. Comprehend and comply with all safety and company policies and procedures.

• Attend training classes, workshops, meetings, etc., as needed to improve job skills and product-related procedures.

Education Minimum:

• B.A./B.S. in Mechatronics, Engineering, Engineering Technology Automated Sciences, Computer Science, Biology, Chemistry or equivalent. (with expected graduation no later than June 2024)

Qualifications:

• Ability to do all required gowning and personal protective equipment ex. Powered Air Purifying Respirator.

• Strong attention to detail and documentation skills are required

• Ability to communicate and work in partnership with other employees in a manufacturing environment

• Ability to prepare Standard Operating Procedures and current GXP documents.

• Demonstrated skills in problem-solving and troubleshooting.

• Effective communication skills, both verbal and written.

Preferred:

• Experience with smart technologies, such as robots, automated systems and/or computer integrated manufacturing equipment (mechatronics).

• Experience operating, setting up, disassembling, and adjusting complex equipment, e.g. robotics, packaging machinery, automatic assembling machines

• Knowledge and experience of sterile drug product manufacture, equipment, and aseptic technique.

• Experience with quality systems

• Experience with new GMP facility startup.

• Knowledge of Investigational drug regulatory requirements.

• Comprehension of Clinical Supply Chain Operations.

• Experience supporting Commissioning, Qualification and Validation.

• Experience in supporting quality investigations and change management.

Working conditions:

• This position may have varying hours based on the needs of the business

• Flexibility working overtime is a requirement in manufacturing

• Travel maybe necessary during facility construction/startup

Travel:

• Up to 10% of the time.

NOTICEFORINTERNALAPPLICANTS

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.

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

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.

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:

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We 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.

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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, generally Tuesday, Wednesday and either Monday or 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”.

Under New York State, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education.

Expected salary range:

$68,400.00 - $107,700.00

Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. For Washington State Jobs, a summary of benefits is listed here.

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 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:

Regular

Relocation:

Domestic

VISA Sponsorship:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Not Applicable

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

N/A

Requisition ID:R280445