Sr. Process Engineer

POSITION OVERVIEW:

The Sr. Process Engineer will leverage expertise in quality systems, change management, label lifecycle management, project management, and process improvements to drive compliance, efficiency, and innovation in packaging and labeling. This position requires a strong understanding of regulatory requirements, technical excellence, and the ability to work cross-functionally to support critical business initiatives.

KEY RESPONSIBILITIES:

(This list is not exhaustive and may be supplemented and changed as necessary.)

• Maintain and enhance packaging and labeling quality systems to ensure compliance with FDA, EMA, and related regulations.
• Develop/improve standard operating procedures (SOPs), work instructions, and quality documentation related to packaging and labeling processes with a focus on lifecycle management.
• Lead and implement change management strategies for packaging and labeling, supporting product lifecycle changes and minimizing operational impact.
• Manage and review label change requests (LCR) to ensure timely, accurate, and compliant label updates.
• Collaborate with regulatory, quality, and manufacturing teams to evaluate and execute changes, supporting a first-time-right approach.
• Plan, execute, and oversee packaging and labeling projects from concept through implementation, ensuring alignment with product launch timelines and regulatory requirements.
• Develop project scopes, timelines, and resource plans to ensure seamless coordination with cross-functional teams.
• Identify project risks and implement risk mitigation strategies including process improvements, supply chain redundancy, and regulatory compliance.
• Analyze existing packaging and labeling workflows, identify opportunities for process improvements, and implement best practices to increase efficiency and reduce risk.
• Drive continuous improvement initiatives to streamline labeling and packaging processes, enhancing compliance, productivity, and cost-effectiveness.
• Provide technical expertise and troubleshooting support for packaging and labeling issues, including root cause analysis and corrective action planning.
• Support manufacturing labeling operations including support, issue trending, and improvement projects.
• Ensure that all packaging and labeling specifications meet regulatory/process standards.
• Serve as a key liaison between quality assurance, manufacturing, regulatory affairs, and supply chain to align labeling strategies with overall business objectives.
• Support product launches, updates, and regulatory requirements by coordinating with cross-functional teams to achieve timely and compliant product releases.

QUALIFICATIONS AND REQUIREMENTS:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the education, experience, skills, knowledge, and abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties.

Education:

• Bachelor’s degree in Engineering, regulatory affairs, or a related field.

Technical Experience:

• Minimum of 7-11 years of experience in pharmaceutical packaging and labeling, with specific expertise in sterile injectables and medical devices.
• Deep understanding of cGMP, FDA, EMA, and USP guidelines relevant to packaging and labeling, and experience filing label artwork changes.
• Proficiency with quality systems including change control and quality events, proficiency in labeling equipment, label artwork review, and compliance.
• Demonstrated success in managing multiple projects in parallel.

Knowledge, Skills, and Abilities:

• Excellent communication skills with the ability to work effectively across departments and influence stakeholders.

ESSENTIAL FUNCTIONS:

Physical Demands:

The physical demands described here are representative of the requirements that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• While performing the duties of this job, the employee is regularly required to use a computer keyboard and mouse; reach with hands and arms; talk and listen. The employee is frequently required to walk and sit, as well as to lift and carry objects such as books and files weighing up to 25 pounds. The employee is occasionally required to stand, stoop, or kneel. Specific vision abilities required by this position include close vision and the ability to adjust focus.

Work Environment:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job, including moderate noise level, an indoor temperate environment, and light levels that are bright and conducive to minimal eye strain, typical for an office environment.

TOTAL REWARDS PROGRAM:

We define total rewards as compensation, benefits, remote work/flexibility, development, recognition and our culture with programs that support each of our reward pillars.  This includes a market competitive base salary and annual incentive plan, robust benefit offerings, and ongoing recognition and career development opportunities. Employees also enjoy our generous flexible paid time off program, company paid holidays, flexible working hours, and fully remote work options for most positions and the ability to work “almost anywhere”. However, if a physical work location is more for you, we have office locations in Greater Boston; San Diego, CA; Boulder, CO; and India.

COMPENSATION:

Our compensation reflects the cost of labor across several US geographic markets. The base pay for this position ranges from $125,537.14 yearly in our lowest geographic market up to $188,305.70 yearly in our highest geographic market. Pay is based on several factors including market location and may vary depending on job-related knowledge, skills, and experience.

Applicants must have current work authorization when accepting a position at Syner-G. Currently, Syner-G is unable to sponsor or take over sponsorship of an employment Visa at this time.