Senior Process Engineer II

Job Title:
Senior Process Engineer II

Job Overview:
The Senior Process Engineer II will provide technical expertise and oversight for equipment lifecycle, process improvements, validation, and compliance within a regulated manufacturing environment. This role is responsible for evaluating and approving engineering and process changes while ensuring alignment with regulatory requirements. The ideal candidate will combine strong technical writing, problem-solving, and leadership skills to drive process reliability, mentor team members, and support the evolving needs of a contract manufacturing environment.

Job Responsibilities:

• Provide technical assessments, rationales, and approvals for engineering and process changes.

• Develop and maintain documentation related to equipment lifecycle, qualification, audit responses, and validation.

• Monitor and analyze manufacturing data to support process improvements and investigations.

• Lead and support process FMEAs to identify and mitigate process and product risks.

• Mentor and train team members to build technical expertise within the group.

• Ensure successful process validation and comparability runs by assessing risk, troubleshooting issues, and implementing preventative measures.

• Lead investigations using DMAIC methodologies to identify root causes, assess impacts, and implement corrective actions.

• Collaborate with cross-functional teams to support production activities and process advancement.

• Evaluate and introduce new technologies and automation for GMP manufacturing.

• Author technical documentation including protocols and reports for equipment qualifications, process validation, and comparability studies.

• Execute engineering studies, recipe development, and validation test cases.

• Partner with vendors and suppliers to define requirements and specifications.

• Adapt to the changing needs of the manufacturing environment, including flexible scheduling as required.

Qualifications:

• Bachelor’s degree or higher in engineering, bioengineering, or a related scientific field.

• 10 or more years of experience in the biopharmaceutical or other GXP-regulated industry.

• Strong expertise in sterile injectables, including formulation, aseptic filling, inspection, and/or packaging.

• Proficiency in data management tools and root cause methodologies (RCM).

• Demonstrated ability to lead technical investigations, process validation, and equipment qualification.

• Excellent oral and written communication skills with strong technical writing ability.

• Experience in contract manufacturing (CMO/CDMO) preferred.

• Technical certifications and/or Lean Six Sigma certification preferred.

• Practical electro-mechanical experience a plus.