Sr Process Control Engineer

Process Engineer (General) Responsibilities:

Process Engineers support both conceptual and detailed design, assist in process scale-up, product development, process validation, and the implementation of operational improvements to resolve manufacturing process challenges as needed.

Engineer's Core Responsibilities:

• Independently design experiments and analyze data to support process improvements and investigations.

• Assist with failure investigations and implement solutions (CAPAs) that resolve manufacturing and product issues, following up to assess their effectiveness and suitability, while preparing or reviewing written reports promptly.

• Prepare technical reports to support process changes, optimizations, and regulatory filings.

• Provide technical guidance and leadership to less experienced team members.

• Ensure proper documentation of qualification and validation records, Change Controls, Risk Assessments, and CAPAs for future compliance audits.

Requirements:

Demonstrated experience in:

• Chiller Design

• P&IDs

• Electrical Systems

• Piping

• Instrumentation

• Solvent Process

• APIs

• Strong understanding of biological process validation, including drug substance manufacturing, drug product filling, process simulations (e.g., media fills), filtration, mixing, sterilization, lyophilization, and completion of validation risk assessments and evaluations.

• Comfort with navigating production areas (CNC space, ISO classified rooms, grey space) and an understanding of product flow through various production areas.

• Ability to analyze process data (e.g., temperatures, pressures, valve sequencing) to address equipment-related issues.

• Familiarity with regulatory audits and the ability to gather supporting documentation.

• Proficiency with MS Office and other computer applications.

Onsite Work Requirements:

This position is based in Boulder, CO.

Salary Range (US):

The salary for this position ranges from $70,491 to $127,144 USD, depending on factors such as professional background, training, work experience, location, business needs, market demand, and competitive practices. The actual salary may vary and could fall outside this range based on these factors. This range is subject to change.

Benefits:

• High growth potential and a fast-paced, people-oriented culture.

• Competitive pay with performance-based incentives.

• Company-paid life, short-term, and long-term disability insurance.

• Medical, dental, and vision insurance options.

• FSA, DCARE, and commuter benefits.

• Supplemental insurance options (life, hospital, critical illness, and legal).

• Health Savings Account (HSA).

• 401(k) retirement plan with employer matching.

• Paid time off (with rollover option) and holidays.

• Sick time as needed.

• Tuition reimbursement.

• Team social activities and a fun workplace environment.

• Employee recognition and referral programs.

• Paid parental leave and bereavement leave.