Process Engineer, Sterile/Liquids Pilot Plant

Job Description

Description – Process Engineer

The Sterile/Liquids Pilot Plants (SLP) is located in Bldg. 17 at West Point, PA and is part of the Pharmaceutical Sciences and Device Development (PSDD) organization. The SLP supports the formulation and filling of clinical, stability, and developmental supplies for vaccines, small molecules, and therapeutic proteins. The SLP interfaces with a large network including multiple of our Research & Development Division teams, Sterile Drug Product Commercialization (SDPC), commercial supply, and other pilot plants within the PSDD network.  The SLP supports 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 SLP Process Engineer (PE) provides technical input on sterile processes from a facility and operational standpoint, manufacturing project management oversight, and GMP expertise to ensure timely availability of clinical supplies and development batches to meet Clinical Development program requirements.  The PE is the main interface with development scientists for the activities required for the manufacturing of sterile liquid clinical and development batches in the SLP.  PE responsibilities include monitoring the achievement of batch planning and execution progress compared to program timelines with sub-teams and key support functions. The PE will perform key batch activities, such as authoring the batch record, coordinating transfer and receipt of batch inputs, providing shopfloor support during batch manufacture, and sample & batch delivery.

In this role, the PE is expected to leverage their relationships and networks to improve and enhance team dynamics, with guidance from senior team members and leads as needed. The engineer should proactively identify and escalate potential obstacles to drive business results. The engineer prepares and facilitates key team meetings including creating agendas, ensuring appropriate participation, contributing program management insights, and following up to ensure the team continues to make progress towards deliverables. The PE participates in department initiatives and workstreams aimed at improving the way that we work and interact with one another. The PE will utilize their technical subject matter expertise, leverage departmental procedures, and adhere to quality and compliance requirements to execute on batch manufacturing. The PE will own relevant change control and lead deviations, inclusive of impact assessment, root cause analysis, and CAPA identification. Additional responsibilities include the implementation of new technologies and support of process improvement projects.

Qualifications:

Education Minimum Requirement:

Required:  Bachelors of Science in Chemical Engineering, Chemistry, Biology or related Scientific Field    

 

Required Experience and Skills:

• Minimum of 1.5 years in a technical or operations support role

• Knowledge of manufacturing equipment and Good Manufacturing Practices

• Strong communication skills, both oral and written. Knows when and how to speak up and appropriately raise issues to team and to management. Keeps both team members, departmental colleagues (as appropriate), and management fully apprised of project initiative status and issues at the right level of detail.

• Effective interpersonal skills and ability to work collaboratively across diverse teams and networks; able to foster cooperation in others, using the diverse perspectives of others to generate ideas.

• Ability to succeed in a dynamic environment with flexibility to respond to changing priorities.

• Demonstrated ability to generate innovative solutions to complex problems and effectively work with and communicate to key stakeholders.

Preferred Experience and skills:

• Sterile process manufacturing and/or formulation development

• Project management 

• Cross functional leadership

• Change Control

• Deviation Management

• Strong technical writing

Location: West Point, PA

Required Skills:

Adaptability, cGMP Guidelines, Personal Initiative, Process Engineering, Process Optimization, Product Formulation, Standard Operating Procedure (SOP) Writing, Sterile Manufacturing, Teamwork, Technical Writing, Troubleshooting

Preferred Skills:

Electronic Batch Records, Laboratory Research, Pilot Plant Operations

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.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.  As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.  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 together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills 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, Monday - 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”.

The salary range for this role is

$87,300.00 - $137,400.00

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits.  Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.

You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance

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:

Yes

Hazardous Material(s):

n/a

Job Posting End Date:

04/15/2026

*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.