Senior Aseptic Process Engineer

Actalent; Baltimore (MD); On-site; USD 138,000 - 172,000; Full time

Benefits offered by this job

Medical, dental & vision

401(k) Retirement Plan

Life Insurance

Disability insurance

Health Spending Account

Transportation benefits

Employee Assistance Program

Paid Time Off

Job summary

Actalent in Baltimore, MD is seeking a Senior Aseptic Process Engineer to lead evaluation, vendor collaboration, and implementation planning for aseptic process improvements in a regulated manufacturing setting. The role requires deep experience with legacy aseptic filling operations, single-use systems, and GMP engineering to reduce open exposure and improve process robustness.

You will translate contamination risks into technical requirements, develop URS and process diagrams, and guide

Qualifications

• Bachelor's degree in engineering or related discipline; advanced degree a plus.
• Approximately 10+ years of experience in process engineering within sterile pharmaceutical or biologic manufacturing.
• Experience in improving or modernizing legacy aseptic filling operations.
• Direct experience with vial and/or syringe filling and sterile filtration.
• Understanding of first-air protection and contamination mechanisms.
• Experience with single-use systems and aseptic connectors.
• Working knowledge of GMP engineering and design expectations.
• Ability to develop detailed engineering documentation.

Responsibilities

• Assess legacy aseptic filling and setup practices, including equipment and component reviews.
• Translate contamination mechanisms and intervention-risk findings into engineering requirements and design concepts.
• Lead technical evaluations of single-use bags, tubing assemblies, and closed-product-pathway options.
• Collaborate with vendors for solutions and compatibility reviews; develop custom assemblies if needed.
• Develop process flow diagrams, assembly drawings, and User Requirements Specifications.

Skills

Bachelors degree in Engineering

10+ years experience

Sterile pharmaceutical manufacturing

Vial/syringe filling

GMP knowledge

Engineering documentation

Education

Bachelor's degree in engineering

Tools

Single-use systems

Sterile filtration equipment

Job description

Job Title: Senior Aseptic Process Engineer Job Description
The Senior Aseptic Process Engineer will manage the engineering evaluation, vendor collaboration, feasibility assessments, and integration planning for aseptic process improvements. The role requires overseeing the implementation pathway for selected solutions derived from technical findings and prioritized opportunities.

Responsibilities

• Assess legacy aseptic filling and setup practices, including equipment and component level reviews such as open aseptic connections and sterile filtration assemblies.
• Translate contamination mechanisms and intervention-risk findings into engineering user requirements and design concepts.
• Lead technical evaluations of single-use bags, tubing assemblies, and closed-product-pathway options.
• Collaborate with vendors to identify solutions, conduct fit and compatibility reviews, and develop custom assemblies if necessary.
• Develop process flow diagrams, assembly drawings, and User Requirements Specifications for current and future states.
• Evaluate integration of proposed solutions into existing manufacturing workflows and equipment configurations.
• Assess compatibility and robustness of product-contact materials and processes.
• Develop and verify engineering studies and vendor demonstrations to ensure usability and reduction of open exposure.
• Partner with various departments to define impacts on change control, validation, and procedural practices.
• Prepare feasibility assessments, technical recommendations, and phased implementation roadmaps.
• Support procurement, design review, and installation activities, ensuring effective solution implementation.
• Provide technical ownership to confirm solution effectiveness and reduction of intervention frequency.

Essential Skills

• Bachelors degree in Chemical, Mechanical, Biochemical, Biomedical, Manufacturing, or related engineering discipline; advanced degree is a plus.
• Approximately 10+ years of experience in process engineering or related fields within sterile pharmaceutical or biologic manufacturing.
• Experience in improving or modernizing legacy aseptic filling operations.
• Direct experience with vial and/or syringe filling and sterile filtration.
• Practical understanding of first-air protection and contamination mechanisms.
• Experience with single-use bags, tubing manifolds, and aseptic connectors.
• Working knowledge of GMP engineering and design expectations.
• Ability to develop detailed engineering documentation.

Additional Skills & Qualifications

• Experience engaging suppliers of single-use systems and sterile fluid-transfer solutions.
• Ability to work effectively on the manufacturing floor and develop physical mockups.

Work Environment

The role is based in a manufacturing area with a standard work schedule of Monday to Friday, 9:00 AM to 5:30 PM. The position requires significant on-site presence in Baltimore and involves working in classified and controlled areas. Occasional off-hours support and travel for vendor visits and evaluations may be needed.

Job Type & Location

This is a Contract position based out of Baltimore, MD.

Pay and Benefits

The pay range for this position is $100.00 - $125.00/hr. Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully onsite position in Baltimore,MD.

Application Deadline

This position is anticipated to close on Oct 12, 2026.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email [e-mail] for other accommodation options.

San Francisco Fair Chance Ordinance:
Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector:
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI):
We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.