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Job Description

Position Description:

Specialist, Sterile Engineer

This Sterile Pharm Operations Engineer position will provide engineering support to sterile operations at FLEx (Formulation, Laboratory & Experimentation) center in Rahway NJ under the remit of Our Company's Research Labs Pharmaceutical Sciences (Pharm Sci), Pharmaceutical Operations Engineering group (Pharm Ops Engineering). Engineering group is responsible to maintain process and utility equipment in a validated state and to provide reliable uninterrupted business continuity.

The FLEx sterile area supports the formulation and filling of clinical, stability, and developmental supplies for biologics and vaccines, including critical program needs related to new products undergoing process development, new products undergoing scale-up, launch and transfer to the supply network and existing commercial products undergoing process optimization. The area is currently under construction, primary responsibility will be to apply relevant experience to contribute to equipment and facility design, system commissioning/qualification, maintenance and calibration data build, as well as other GMP operational readiness critical activities to enable facility startup.

Post turn-over from project, it will be to maintain all equipment in accordance with GMP and Safety requirements, as well as exercising Reliability Maintenance best practices to ensure timely availability of Clinical Supplies and Development Batches to meet Clinical Development Program requirements. Work collaboratively with various partner groups such as operations, equipment vendors, site maintenance, quality.

Provide quality engineering support that includes authoring and executing commissioning and qualification protocols and summary reports for utilities, process, and support equipment. Responsible to execute capital and expense equipment related projects. Provide capital project administration (processing capital requests and administering capital project closeout activities). Maintain GMP documentation where applicable, such as GMP engineering drawings, post-approved qualification documents, and equipment database tracking. Facilitate and/or participate in deviations reporting, investigations and any related corrective action/preventive action (CAPA). Facilitate equipment/system change controls, execute periodic reviews and support Quality Management System (QMS) activities. Provide technical expertise, troubleshooting and improved equipment reliability/performance. Partner with cross-functional teams to implement sterile validation program. Contribute to the planning, design, and execution of validation procedures and studies. Actively participate to achieve program deliverables.

Interface with site engineering and maintenance groups, as well as outside service providers to create maintenance and calibration data build. Establish partnership with contractors, vendors, outside service providers to manage service level agreements. Ensure appropriate equipment spare part inventories are established and maintained as required. Create and manage lockout/tagout and hazardous energy control procedures. Support mechanical aspects of clinical operations, including support/initiation and gatekeeping of work orders, placing/expediting expense purchase orders, managing budgets, asset depreciation, and coordinating mechanical work performed by maintenance personnel, contractors/vendors and facility operating staff.

Position Qualifications:

Education Minimum Requirement:

• Bachelor's Degree in Engineering or Science plus a minimum of 2 years of related sterile experience.

Required Experience and Skills :

• Familiarity with Quality, cGMP, Safety & Environmental Policies and Procedures.

• Technical writing validation documents, protocols, investigations, change requests, standard operating procedures, etc.

• Maintenance & Engineering techniques and management

• Ability to flexibly adapt to flow to the work across both Quality and Facility aspects to support the business.  

• Demonstrated skills in problem-solving and troubleshooting

• Effective organizational and communication skills (verbal and written).

Preferred Experience and Skills:

• Familiarity with Capital Project systems (administration and execution) as well as Computerized Maintenance and Management Systems (CMMS). 

• Knowledge and experience of sterile drug product manufacture

• SAP Training and skills - Project Manager (PM) role, SAP Plant Maintenance

• Experience with ProCal as the Computerized Calibration Maintenance System (CCMS).

• Sanitization and sterilization validation (SIP, autoclaves, VHP, etc.)

• Equipment qualification experience in support of good manufacturing practices.

• The candidate should be able to work independently and lead or facilitate tasks successfully.

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.

#EligibleforERP #vetjobs #EBRG

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, 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.

Learn more about your rights, including under California, Colorado and other US State Acts (https://www.msdprivacy.com/us/en/CCPA-notice/)

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:

$83,100.00 - $130,900.00

Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. A summary of benefits is listed here (https://www.benefitsatmerck.com/) .

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:

No relocation

VISA Sponsorship:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Not Applicable

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

N/A

Job Posting End Date:

07/6/2024

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Job Posting End Date: 07/06/2024

A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID: R301104