Staff Process Engineer

Job Description

Job Description

COMPANY DESCRIPTION :

Syner-G BioPharma Group is a science-led, strategic partner for life science companies. We provide integrated regulatory and biopharmaceutical development services spanning early development to post-market, along with operational strategy and support. With a global team of 400 employees across North America and India, our goal is to help our partners navigate the complexities of product development and accelerate their journey to market.

We are a leading life sciences consultancy committed to advancing human health by helping organizations bring life-saving innovations to market faster, at scale, and with the highest quality.

Our team partners with a diverse range of clients across the life sciences industry, supporting critical phases of the drug development lifecycle, from discovery and regulatory approval to technology transfer and the support in capital projects. We provide strategic guidance and hands-on expertise to streamline operations, enhance quality systems, and ensure regulatory compliance, empowering our clients to navigate complexity and deliver impactful therapies to patients worldwide.

Syner-G BioPharma Group was recently honored with BioSpace's prestigious "Best Places to Work" 2025 award, for the second consecutive year, along with many other award-winning programs to make a career here truly life-enhancing. These recognitions are a testament to our commitment to fostering a positive and engaging work environment for our employees, with a particular emphasis on culture, career growth and development opportunities, financial rewards, leadership, and innovation.

At Syner-G, we recognize that our team members are our most valuable asset. Join us in shaping the future, where your talents are valued, and your contributions make a meaningful impact.

For more information, visit www.Synergbiopharma.com

POSITION OVERVIEW

We are seeking a Staff Process Engineer / Project Engineer with deep expertise in manufacturing and packaging equipment, process engineering, and project execution. This hybrid role combines technical leadership in process engineering with project management responsibilities to drive compliance, efficiency, and innovation across manufacturing operations. The ideal candidate will have a strong understanding of regulatory requirements, equipment commissioning, and cross-functional collaboration to support critical business initiatives.

KEY RESPONSIBILITIES

• Reviewing equipment drawings and specifications to ensure alignment with process requirements and regulatory standards
• Creating, reviewing, and approving Turnover Packages (TOPs) and other commissioning documentation
• Verifying Owner-Furnished Contractor-Installed (OFCI) equipment lists for accuracy and completeness
• Scoping, selecting, and reviewing transmitters, sensors, and instrumentation for manufacturing and packaging equipment
• Supporting equipment commissioning and qualification activities, including FAT / SAT and IQ / OQ documentation
• Providing process engineering input during design reviews, equipment selection, and installation phases
• Maintain and enhance manufacturing and packaging quality systems to ensure compliance with FDA, EMA, and related regulations
• Develop and improve SOPs, work instructions, and quality documentation related to manufacturing and packaging processes with a focus on lifecycle management
• Lead and implement change management strategies for manufacturing and packaging, supporting product lifecycle changes and minimizing operational impact
• Manage and review equipment change requests to ensure timely, accurate, and compliant updates
• Collaborate with regulatory, quality, and manufacturing teams to evaluate and execute changes, supporting a first-time-right approach
• Plan, execute, and oversee manufacturing and packaging 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 manufacturing and packaging workflows, identify opportunities for process improvements, and implement best practices to increase efficiency and reduce risk
• Drive continuous improvement initiatives to streamline manufacturing and packaging processes, enhancing compliance, productivity, and cost-effectiveness
• Provide technical expertise and troubleshooting support for manufacturing and packaging issues, including root cause analysis and corrective action planning
• Support manufacturing operations including support, issue trending, and improvement projects
• Ensure that all manufacturing and packaging specifications meet regulatory / process standards
• Serve as a key liaison between quality assurance, manufacturing, regulatory affairs, and supply chain to align manufacturing 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
• Act as a product manager for manufacturing and packaging equipment, ensuring that product development aligns with market needs and regulatory standards
• Monitor market trends and competitor products to identify opportunities for innovation and improvement in manufacturing and packaging equipment
• Develop and maintain product roadmaps, ensuring alignment with business goals and customer needs
• Collaborate with marketing and sales teams to develop product positioning and messaging that differentiates our products in the market

QUALIFICATIONS AND REQUIREMENTS

Education

Technical Experience

Proficiency with quality systems including change control and quality events

Knowledge, Skills, and Abilities

ESSENTIAL FUNCTIONS

Physical Demands

Work 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.

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.

LEGAL STATEMENT :

Syner-G BioPharma Group is proud to be an Equal Employment Opportunity and Affirmative Action employers. All employment decisions, including the recruiting, hiring, placement, training availability, promotion, compensation, evaluation, disciplinary actions, and termination of employment (if necessary) are made without regard to the employee's race, color, creed, religion, sex, pregnancy or childbirth, personal appearance, family responsibilities, sexual orientation or preference, gender identity, political affiliation, source of income, place of residence, national or ethnic origin, ancestry, age, marital status, military veteran status, unfavorable discharge from military service, physical or mental disability, or on any other basis prohibited by applicable law. Syner-G BioPharma is an E-Verify employer.