Join our Biotherapeutics Pharmaceutical Research & Development – Drug Product Design & Development team as an experienced engineer, supporting the selection, qualification, and implementation of components and container closure systems for early and late-stage projects. You will work closely with vendors, SMEs, and commercial teams to ensure compliance with regulatory requirements, author technical documentation, and facilitate design verification activities for prefilled syringe and combination products. Key responsibilities include driving testing protocols, conducting root cause analyses, and collaborating across Quality, Regulatory, Manufacturing, and other departments to enhance operational excellence. Ideal candidates possess deep expertise in parenteral packaging and medical device development, proficiency with analytical instruments like Instron and ZebraSci, and a strong understanding of global regulatory standards such as FDA and ISO 13485. This role offers the chance to influence strategy at a global scale while advancing life-changing medicines from development through commercialization.
Skills
Instron
ZebraSci
MIMAS
Computrac
HPLC
UPLC
SEC
LC-MS
BiaCORE
DSC
GC
cGMP
ISO 13485
FDA
ICH
USP
EP
JP compendia
combination product regulations
data processing
report writing
ChatGPT
Microsoft Copilot
What you'll do
Evaluate, develop, qualify, and implement new components and container closure systems for drug products.
Author and review engineering documentation including drawings, specifications, risk analyses, and design verification documents.
Facilitate and execute verification activities for medical devices and combination products to ensure compliance with regulatory standards.
Investigate failures of parenteral packaging and delivery devices to determine root causes and implement corrective actions.
Drive testing protocols and technical reports for medical devices and combination products in collaboration with cross-functional teams.
Support the transfer of new drug products to commercial manufacturing and post-launch support teams, ensuring seamless transitions.
What we're looking for
Bachelor's degree with 9-11 years or Master's degree with 7-8 years of relevant experience.
Strong technical skills in formulation development, process optimization, and parenteral packaging.
Proficiency in using analytical instruments and knowledge of testing equipment (Instron, ZebraSci, etc.).
Experience in cGMP manufacturing and clinical trials supply chain management.
Excellent organizational, time management, communication, and critical thinking skills.
In-depth understanding of global regulatory standards and ability to interface with regulatory agencies.
Market check
Salary context
This
$93,600–$156,000
range sits above
18%
of similar postings on FindRole.
Peer median band
$124,127–$198,000
Median floor and ceiling across peers.
Typical midpoint (25–75%)
$137,525–$192,500
Middle half of comparable postings.
Based on 240 comparable postings.*
* 240 is the maximum number of comparable postings sampled.
Employer
About Pfizer
Pfizer Inc. is one of the world''s largest biopharmaceutical companies, researching, developing, manufacturing, and marketing medicines and vaccines across multiple therapeutic areas including oncology, cardiology, and infectious diseases. Industry: Biopharmaceuticals
Pfizer currently has
18 open roles
on FindRole.
Listed pay typically runs
$106,000–$176,600
across 18 roles with salary data.
San Diego, Ca,Us, US150 days ago
$154,000–$231,000
Flip Chip
Wire Bond
System in Package (SiP)
Design for Manufacturability (DFM)
Failure Mode and Effects Analysis (FMEA)
Laser Groove Technology
Package Manufacturing
Technical Project Management
Reliability Test Methods
Six Sigma