Pharmaceutical Operations and Clinical Supply is looking for a highly motivated candidate to support specialty dosage forms and oral solid dosage GMP development operations as a Specialist, Engineering – Cleaning and Production Engineer.
The Specialist, Engineering is generally in charge of leading the facility’s equipment cleaning. This primary responsibility will be supplemented by other production engineer tasks. Working with process engineers ahead of time to design a cleaning plan, draft cleaning protocols, cleaning paperwork, and follow equipment through the process to release are all part of this. This professional would be in charge of any failed investigations. Furthermore, the specialist would be the facility’s cleaning expert, answering queries, evaluating choices for new issues, and teaching new engineers the procedure. Previous cleaning documentation and management experience is required.
This engineer would be a member of the production team, contributing to the facility’s operations via teaching on equipment and leading troubleshooting. This engineer could help with batch production or ad hoc equipment duties including training and containment verifications as needed. The engineer would lead new equipment through the cleaning evaluation and may provide extra new equipment introduction advice from a production/operations standpoint.
Primary roles include:
Cleaning documents ownership and subject matter expert, including:
- Master plan for validation
- Cleaning Procedures
- Introduction of a new procedure
- Introduction of new equipment
- Cleaning examinations
- Cleaning SOPs and forms have been updated.
- We are also redesigning our cleaning process. This person would oversee the completion of this change and may assist in giving trainings after the changes are implemented.
- Strong collaboration with analytical team for cleaning technique development, release method determination, and equipment release via swab testing.
- Development and execution of OEB 4/5 cleaning procedures
- Coaching and training team members to complete cleaning jobs successfully
Additional activities include:
Responsibilities of a production engineer include:
- Assisting with safety and environmental audits and improvements
- Developing equipment knowledge to lead troubleshooting
- Support operations staff by improving processes and participating in events as needed.
- Quality investigations at the forefront
- Scheduling, mechanical planning, and on-the-floor support may also be assigned duties.
- Bachelor’s degree (preferred in chemical engineering, chemistry, pharmaceutical engineering, or a related discipline)
- 2+ years of pharmaceutical manufacturing/production experience
- Previous experience managing cleaning documentation
We are searching for someone that is detail focused, efficient with paperwork, and has a growth attitude. The successful applicant will spend time on the floor as well as directing documents through reviews and approvals, and time management is a vital skill to balance these two priorities.
NOTICE TO INTERNAL APPLICANTS
All workers subject to this policy must have a minimum of twelve (12) months of service in their present position before applying for available positions, according to Managers’ Policy – Job Posting and Employee Placement.
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 specified in your separation package’s Summary Plan Description (SPD), you are no longer eligible for your separation benefits package.Please contact your HRBP or Talent Acquisition Advisor for a more detailed discussion.
Employees working in roles requiring 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 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, your employment may pose an undue burden on business operations, in which case you may not be offered employment or your employment may be terminated, as permitted by applicable law. Please also keep in mind that, where authorised by legislation, the Company reserves the right to demand COVID-19 immunisations for roles such as Global Employee Health, where the Company considers in its sole discretion that the nature of the work poses an enhanced risk of disease transmission.
Residents of the United States and Puerto Rico only:
Our organisation is dedicated to diversity and inclusion, guaranteeing that candidates may participate in a hiring process that demonstrates their actual talents. If you require an accommodation during the application or employment process, please click here.
We are an Equal Opportunity Employer dedicated to creating a welcoming and diverse workplace.All competent applicants shall be considered for employment regardless of race, colour, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, handicap status, or any other legally protected characteristics.For more information on personal rights under Equal Opportunity Employment regulations in the United States, go to:
We are delighted to be a company that values bringing together diverse, talented, and passionate individuals. When various ideas come together in an inclusive setting, it is the quickest approach to breakthrough innovation. We urge our coworkers to respectfully challenge one another’s thinking and work together to solve difficulties.
Hybrid Work Model in the United States
Employees in office-based positions in the United States will be working a Hybrid work schedule beginning September 5, 2023, consisting of three total days on-site per week, generally Tuesday, Wednesday, and either Monday or Thursday, though the specific days may vary by site or organisation, 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 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 that the job requirements cannot be reasonably met working remotely. Please keep in mind that this Hybrid work model guidance does not apply to roles marked as “remote.”
The Company is required by law in New York State, Colorado State, Washington State, and California State to offer a reasonable estimate of the compensation range for this employment. Salary determinations will be based on a variety of variables, including, but not limited to, the primary work location and the chosen candidate’s appropriate skills, experience, and education.
Salary range expected:
$83,100.00 – $130,900.00
Bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days are all available.A summary of benefits for Washington State Jobs can be found here.
Representatives of Search Firms Please read this carefully.
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited employment opportunities from search firms. Without a clear signed search agreement in place for this position, any CVs / resumes submitted by search firms to any employee at our company would be deemed the sole property of our organisation.If a candidate is employed by our organisation as a consequence of an agency reference and there is no pre-existing agreement, no fee will be paid. Introductions are position specific where agency agreements are in existence. No phone calls or emails, please.
Requirements for Travel:
- There is no need for travel.
Flexible Working Conditions:
- 1st – Day
A valid driver’s licence:
- pharmaceutical active compounds
REQ ID: R274538.