Sr Process Engineer/Process Engineer
New Today
Job Description
We are seeking a hands-on, detail-oriented Sr. Process Engineer/Process Engineer to join our dynamic biotech startup. This role is pivotal in scaling up formulation processes, qualifying instrumentation, improving process efficiency, and supporting technology transfer from R&D to Manufacturing. The ideal candidate thrives in a fast-paced, collaborative environment and brings a strong foundation in bioprocessing, formulation science, and GMP operations.
Duties and Responsibilities
- Lead process development and scale-up activities from lab to pilot and manufacturing scale, ensuring consistency and quality.
- Design and execute instrument testing and qualification protocols (IQ/OQ/PQ) and support the commissioning of new systems.
- Identify and support implementation of semi-auto and automation platforms to enhance flexibility and reduce turnaround times for filling, sealing, and packaging processes.
- Collaborate with cross functional teams (R&D, QC, Engineering, Facilities) and Manufacturing teams to ensure seamless technology transfer and process validation.
- Support technology transfer activities, including documentation, training, and troubleshooting during manufacturing scale up.
- Author and maintain standard operating procedures (SOPs), batch records, and technical reports in compliance with Alamar standards and regulatory standards.
- Champion projects to optimize processes for yield, robustness, and cost-effectiveness.
- Analyze process data to identify trends, deviations, and opportunities for continuous improvement.
- Ensure compliance with GMP, safety, and regulatory standards throughout all operations.
- Contribute to cross-functional project teams and provide technical expertise during audits and inspections.
Qualifications:
- Bachelor or Master's degree in Mechanical Engineering, Biomedical Engineering, or related fields.
- 7+ years of experience in a biotech, pharmaceutical, or life sciences environment.
- Proven experience in reagents formulation development and manufacturing process scale-up.
- Experienced in equipment qualification and validation practices.
- Excellent problem-solving and project management skills.
- Effective verbal and written communication skills
- Ability to work independently and collaboratively in a fast-paced dynamic environment.
- Strong understanding of ISO 13485/GMP manufacturing and regulatory expectations.
The base salary range for this full-time position is $130,000.00 - $150,000.00 + bonus + equity + benefits. Our salary ranges are determined by work location, job-related skills, experience, and relevant education or training. The ranges displayed on each job posting reflect the minimum and maximum target for new hire salaries but are subject to change if the leveling of the role is adjusted. Your recruiter can share more about the specific salary range during the hiring process.
- Location:
- Fremont
- Job Type:
- FullTime
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