The Senior Specialist would be responsible for leading the planning, design, and implementation of engineering solutions on a suite team within a large capital project or leading small capital projects less than $100MM in value. Core work includes equip/scope generation, process & facility design, equipment selection, vendor interaction, factory acceptance testing, technology transfer, construction support, equipment qualification, facility start-up and process demonstrations. The role may involve supervising junior engineers and collaboration with resources from an engineering firm.

The Senior Specialist primary responsibility entails:

• Exhibiting strong technical/engineering leadership, interpersonal, collaboration and communication skills for both decision making and guiding team members.
• Leading a cross functional suite team of 5-10 members through the stage gates of a project and setting them up for success with knowledge transfer.
• Ensuring deliverables conform to our company's standards and practices; and are technically sound.
• Providing technical guidance during project implementation, assures viability of technology to meet design intent.
• Collaborating with other technical functions to ensure successful technology transfers of new and in-line products.
• Flexibility with travel up to 35%.

This position will function as the technical/engineering process lead engineer/project design manager with prior experience supporting Biologics, Vaccine and/or Sterile Projects and Drug Product manufacturing.

Minimum Education Requirement and Experience:

• Bachelor of Science (B.S.) degree in Engineering (Chemical or Mechanical), Science, or Business with five (5) years of experience in Pharmaceutical/Biotech industry such as Process-Equipment Engineering Design, Capital Project implementation, Technical Operations, or Operations/EMU. OR
• Master of Science (M.S.) degree in Engineering (Chemical or Mechanical), Science, or Business with three (3) years of experience in Pharmaceutical/Biotech industry such as Process-Equipment Engineering Design, Capital Project implementation, Technical Operations, or Operations/EMU.

Required Experience and Skills:

• Three (3) years' experience leading cross functional teams in the startup and C&Q execution of capital projects.
• Drug Product filling experience - start up, operation, troubleshooting of filling equipment.
• Experience with an equipment life cycle approach including specification, selection, testing & commissioning, troubleshooting and qualification.
• Understanding of hygienic design and unit operations specific to vaccine/biologic manufacturing and aseptic processing in the areas of Buffer Prep, Formulation, and CIP/SIP.
• Experience with capital projects that followed a stage gate capital management process.
• Excellent collaboration and engagement as a team player with dependable interpersonal and communication skills.
• Analytical and problem-solving skills.
• Multitasking/time management skills which deliver on time and quality work.
• Core knowledge should include specification of unit operations, P&ID reviews, Hazard Analysis, equipment operation, commissioning & qualification execution.
• Work independently and meet timelines in a fast-paced team-based environment.
• Strong self-motivation; proactive, high-energy, "can do" work ethic; ability to handle potentially stressful situations with a positive attitude.

Preferred Experience and Skills:

• An advanced degree in Engineering, Science, or Business is preferred.
• Possess experience with engineering design, equipment operation and startup, and managing the growth and development of junior level engineers.
• Should demonstrate a proven aptitude for leading project design endeavors and offering creative solutions that align with business objectives.
• Previous managerial experience in a similar position is desirable.

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, 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".

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:
No relocation

VISA Sponsorship:
No

Travel Requirements:
25%

Flexible Work Arrangements:
Not Applicable

Shift:
1st - Day

Valid Driving License:
No

Hazardous Material(s):
n/a

Job Posting End Date:
11/26/2024
*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:R320436