Associate Principal Scientist/Engineer, Medical Device and Combination Products, ISO/DV Testing Manager

Merck; West Point (PA); On-site; USD 142,000 - 224,000; Full time

Benefits offered by this job

Annual bonus

Long-term incentive

Medical benefits

401(k)

Job summary

Merck’s Center for Packaging & Device Analytics (CPDA) in West Point, PA seeks an Associate Principal Scientist/Engineer to manage design verification testing and method validation across internal and external labs. You will lead DV activities for commercial MDCP products and ensure cGMP, ISO 13485, and GDP compliance.

You will mentor CPDA analysts, collaborate with program leads to advance analytical technologies, and contribute to safe, compliant testing and documentation in a fast-paced

Qualifications

• A minimum of 3 years with PhD, or 6 years with BS or MS, in an industry role centered on analytical testing.
• Successful work within a cGMP or ISO 13485 certified analytical laboratory.
• Strong knowledge and experience with regulatory compliance principles GMPs, GDPs and quality assurance practices related to analytical testing

Responsibilities

• Strategic and tactical (day-to-day) management of design verification testing to support commercial products and meet project timelines.
• Technical oversight of method development, validation, and implementation at internal and external laboratories.
• Ensuring safety, environmental and cGMP & ISO 13485 compliance for all lab activities and operations.
• Drive test method development and implementation of new instrumentation/analytical technologies for the lab.
• Oversight and technical coaching of CPDA analysts in the ISO laboratory.

Skills

Analytical Development

Analytical Testing

GMP Laboratory

GMP Testing

Interdisciplinary Collaboration

Mechanical Testing

Medical Device Management

Medical Devices

Medical Device Technologies

Medical Device Testing

Synthetic Chemistry

Test Procedure Development

Education

BS, MS or PhD in Mechanical, Chemical or Biomedical Engineering or associated scientific discipline, such as Chemistry

Job description

Job Description

The Center for Packaging & Device Analytics (CPDA), within our Manufacturing Division, has responsibility for applied physical, material & analytical science to support production and commercialization of product packaging and drug-delivery medical device/combination-products (MDCPs), such as auto-injectors and pre-filled syringes. We are an interdisciplinary engineering science Center of Excellence that supports the entire global human-health portfolio and partners closely with various Packaging or Device Technology engineering groups, assembly/packaging sites, and partner analytical groups. The CPDA is located at our company's large research and manufacturing site at West Point PA, where our packaging & device laboratories are established.

The CPDA is seeking an Associate Principal Scientist/Engineer for an exciting opportunity to manage and oversee formal MDCP method validation/transfer and design verification testing activities in our dedicated ISO design verification (DV) laboratory [internal] and partner contract laboratories [external]. Responsibilities will include:

• (1) strategic and tactical (day-to-day) management of design verification testing to support our commercial products to meet critical project timelines,
• (2) technical oversight of method development, validation, and implementation of analytical methods and associated investigational support at both internal and external laboratories,
• (3) ensuring safety, environmental and cGMP and ISO 13485 compliance for all laboratory activities and operations,
• (4) collaborating with CPDA program leads to drive test method development, validation and implementation of new instrumentation/analytical technologies for the laboratory to support current and future commercial MDCP DV testing, and,
• (5) oversight and technical coaching of CPDA analysts in the ISO laboratory.

To excel in the role, one must be creative and skillful in problem solving and applied experimental physical science relevant to mechanical devices. Key leadership behaviors include communication (written and verbal), collaboration, technical coaching and development with a compliance mindset, and accountability for lab operational excellence and delivery.

Required Education

• BS, MS or PhD in Mechanical, Chemical or Biomedical Engineering or associated scientific discipline, such as Chemistry.

Required Experience

• A minimum of 3 years with PhD, or 6 years with BS or MS, in an industry role centered on analytical testing.
• Successful work within a cGMP or ISO 13485 certified analytical laboratory.
• Strong knowledge and experience with regulatory compliance principles Good Manufacturing Practices (GMPs), Good Documentation Practices (GDPs) and quality assurance practices related to analytical testing

Preferred Experience & Skills

• Demonstrated competency with mechanical testing.
• Successful manager / supervisor of staff within a cGMP or ISO 13485 certified analytical laboratory.
• Expertise with medical device development and understanding/familiarity of Design Controls (21 CFR 820.30), ISO 13485, cGMP, and relevant industry standards.
• Hands‑on experience in MDCP method development, Device Characterization, and Design Verification (DV) for development, engineering studies, design verification, stability studies and/or validation—including analytical strategy and protocol design.
• Advanced expertise with mechanical functionality and strength testing, container closure integrity testing and dimensioning—such as (not limited to) tensile/compression/torsional testing, optical or x‑ray microscopy, optical comparator methods, dye ingress testing, etc.

Required Skills

Analytical Development, Analytical Testing, GMP Laboratory, GMP Testing, Interdisciplinary Collaboration, Mechanical Testing, Medical Device Management, Medical Devices, Medical Device Technologies, Medical Device Testing, Synthetic Chemistry, Test Procedure Development

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.

Requirements

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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Salary

The salary range for this role is

$142,400.00 - $224,100.00

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.

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

Yes

Travel Requirements

10%

Flexible Work Arrangements

Not Applicable

Shift

1st - Day

Valid Driving License

No

Hazardous Material(s)

n/a

Job Posting End Date

• 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:

R407768