Specialist, Engineering
Job DescriptionAre you looking for an exciting opportunity with a rapidly growing pharmaceutical manufacturer? If so, then this is the opportunity for you!ACCOUNTABILITY:
Under the supervision of a Senior Specialist or Associate Director, is responsible for providing technical manufacturing support in the field of engineering, maintenance and utilities (EMU).
Provides day-to-day engineering support for assigned area which may include vaccine bulk manufacturing, filling, lyophilization, packaging, and/or mechanical support utilities including power, HVAC, steam, WFI and controlled temperature units.
Assigned tasks include support and monitoring of equipment performance and maintenance, propose & develop equipment and facility improvements and troubleshoot process equipment to ensure reliable, compliant and efficient operations.
Actively ensures GMP quality, safety, environmental, and operating cost goals are achieved.
On occasion, may provide supervisory coverage to ensure supply of a high-quality product.
Position
Responsibilities:
Works with Operations, other EM&U engineers, Technology, Maintenance Supervisors and mechanics to maximize capacity and assure efficient, reliable equipment operation in accordance with all GMP, safety and environmental regulations.
Champions the preventive and predictive maintenance program within your area of responsibility, reviews equipment history for reliability concerns, performs root cause analysis, and identifies reliability improvement opportunities and applications for predictive maintenance technologies to reduce maintenance costs.
Develops maintenance and repair strategy for bi-annual shutdowns.
Assists/leads Operations, maintenance supervisors, mechanics, automation engineers, process engineers and Quality representatives in troubleshooting equipment problems as well as investigating manufacturing atypical events related to system failure or malfunction.
Serves as the project engineer and manager for small projects including scope development, design support, field execution andcommissioning/qualificationtesting.
Identifies spare parts and stand-by equipment needed to assure maximum capacity and reliability.
Supports maintenance scheduling and planning processes in area of responsibility.
Supports positive safety culture and participates in HAZOP reviews and Safety inspections.
Promotes open communications, inclusion and team work.
Authors Standard Operating Procedures or User Manuals and assists in training development for mechanics and supervisors.
Assists in the preparation of process studies, engineering standards, equipment utilization, and profit plan.
Explains and enforces all GMPs, safety, and environmental regulations.
Assist in audits, regulatory inspections and training in the area of responsibility.
In accordance with Policy 82 - 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.
Education Minimum Requirement:
B.
S.
Engineering, Science, or 4 Year Engineering Technology Degree.
Required Experience and Skills:
Minimum of two (2) years of manufacturing experience or technical support group or equivalent.
Proficient in the following competencies:
empowering leadership, flexibility, motivation,teamwork/partnership,problem-solving, communication, and computer skills.
Knowledge in the application of engineering standards (i.
e.
ASME, IEEE, NFPA, CFR 1910, NIST, and/or ANSI).
Preferred Experience and Skills:
Knowledge of cGMP for pharmaceutical and/or vaccine manufacturing, Lean Six Sigma Methodology, Root Cause Analysis, Failure Mode Effects Analysis, knowledge in reliability engineering (including asset life cycle management).
Computerized Management Maintenance Systems SAP), and CMRP certification desired.
Note:
This description is not intended to be all-inclusive or a limitation of the duties of the Job.
It is intended to describe the general nature of the job that may include other duties as assumed or assigned.
VETJOBSNOTICE FOR INTERNAL APPLICANTSIn 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 (https:
//wd5.
myworkday.
com/msd/d/inst/1422$1533/rel-task/3001$14.
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.
For more information about personal rights under Equal Employment Opportunity, 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.
We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.
U.
S.
Hybrid Work Model Effective September 5,2023 our U.
S.
Hybrid work model will be as follows:
1.
Three total days on site per week:
Tuesday and Wednesday - plus one additional day of choice based on what works best for organizations and/or teams.
2.
Fridays will formally be a remote-working day unless business critical tasks require onsite presence.
Learn more about your rights, including under California, Colorado and other US State Acts ( https:
//www.
msdprivacy.
com/us/en/CCPA-notice/) />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:
No Travel Required Flexible Work Arrangements:
Shift:
1st - Day Valid Driving License:
Hazardous Material(s):
Requisition ID:
R251008 Recommended Skills Auditing Automation Certified Global Meeting Planner Communication Computer Literacy Development Planning Estimated Salary: $20 to $28 per hour based on qualifications.
Under the supervision of a Senior Specialist or Associate Director, is responsible for providing technical manufacturing support in the field of engineering, maintenance and utilities (EMU).
Provides day-to-day engineering support for assigned area which may include vaccine bulk manufacturing, filling, lyophilization, packaging, and/or mechanical support utilities including power, HVAC, steam, WFI and controlled temperature units.
Assigned tasks include support and monitoring of equipment performance and maintenance, propose & develop equipment and facility improvements and troubleshoot process equipment to ensure reliable, compliant and efficient operations.
Actively ensures GMP quality, safety, environmental, and operating cost goals are achieved.
On occasion, may provide supervisory coverage to ensure supply of a high-quality product.
Position
Responsibilities:
Works with Operations, other EM&U engineers, Technology, Maintenance Supervisors and mechanics to maximize capacity and assure efficient, reliable equipment operation in accordance with all GMP, safety and environmental regulations.
Champions the preventive and predictive maintenance program within your area of responsibility, reviews equipment history for reliability concerns, performs root cause analysis, and identifies reliability improvement opportunities and applications for predictive maintenance technologies to reduce maintenance costs.
Develops maintenance and repair strategy for bi-annual shutdowns.
Assists/leads Operations, maintenance supervisors, mechanics, automation engineers, process engineers and Quality representatives in troubleshooting equipment problems as well as investigating manufacturing atypical events related to system failure or malfunction.
Serves as the project engineer and manager for small projects including scope development, design support, field execution andcommissioning/qualificationtesting.
Identifies spare parts and stand-by equipment needed to assure maximum capacity and reliability.
Supports maintenance scheduling and planning processes in area of responsibility.
Supports positive safety culture and participates in HAZOP reviews and Safety inspections.
Promotes open communications, inclusion and team work.
Authors Standard Operating Procedures or User Manuals and assists in training development for mechanics and supervisors.
Assists in the preparation of process studies, engineering standards, equipment utilization, and profit plan.
Explains and enforces all GMPs, safety, and environmental regulations.
Assist in audits, regulatory inspections and training in the area of responsibility.
In accordance with Policy 82 - 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.
Education Minimum Requirement:
B.
S.
Engineering, Science, or 4 Year Engineering Technology Degree.
Required Experience and Skills:
Minimum of two (2) years of manufacturing experience or technical support group or equivalent.
Proficient in the following competencies:
empowering leadership, flexibility, motivation,teamwork/partnership,problem-solving, communication, and computer skills.
Knowledge in the application of engineering standards (i.
e.
ASME, IEEE, NFPA, CFR 1910, NIST, and/or ANSI).
Preferred Experience and Skills:
Knowledge of cGMP for pharmaceutical and/or vaccine manufacturing, Lean Six Sigma Methodology, Root Cause Analysis, Failure Mode Effects Analysis, knowledge in reliability engineering (including asset life cycle management).
Computerized Management Maintenance Systems SAP), and CMRP certification desired.
Note:
This description is not intended to be all-inclusive or a limitation of the duties of the Job.
It is intended to describe the general nature of the job that may include other duties as assumed or assigned.
VETJOBSNOTICE FOR INTERNAL APPLICANTSIn 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 (https:
//wd5.
myworkday.
com/msd/d/inst/1422$1533/rel-task/3001$14.
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.
For more information about personal rights under Equal Employment Opportunity, 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.
We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.
U.
S.
Hybrid Work Model Effective September 5,2023 our U.
S.
Hybrid work model will be as follows:
1.
Three total days on site per week:
Tuesday and Wednesday - plus one additional day of choice based on what works best for organizations and/or teams.
2.
Fridays will formally be a remote-working day unless business critical tasks require onsite presence.
Learn more about your rights, including under California, Colorado and other US State Acts ( https:
//www.
msdprivacy.
com/us/en/CCPA-notice/) />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:
No Travel Required Flexible Work Arrangements:
Shift:
1st - Day Valid Driving License:
Hazardous Material(s):
Requisition ID:
R251008 Recommended Skills Auditing Automation Certified Global Meeting Planner Communication Computer Literacy Development Planning Estimated Salary: $20 to $28 per hour based on qualifications.
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