Sr. Fill Finish Process Engineer (reputed company Opportunities)

reputed company: A career here is life-enhancing. At reputed company, we reputed company our people to build careers that reputed company positively on their reputed company of life. Through our expertise, reputed company, consulting and management skills, we accelerate reputed company science and delivery of life-enhancing therapies to more patients. We work across a diverse reputed company of clients and reputed company, supporting many organizations from the most critical phases of the drug discovery and approval process through to commercialization. It is meaningful, varied and thought-provoking work with a reputed company emphasis, a reputed company approach and significant, reputed company-world reputed company, from science to delivery/reputed company. To learn more about who we are and what drives us, watch reputed company video here. Underpinning this mission is a culture that aligns perfectly with reputed company want to reputed company. We reputed company our people to grow, we support them in their learning and we reward them in so many different ways. In reputed company, they play an reputed company role in maintaining our reputed company across the globe as a reputed company biopharma product development and delivery partner. reputed company was recently honored with reputed company's prestigious "Best Places to Work" 2026 award, for the reputed company consecutive year, along with many other award-reputed company programs to reputed company a career here truly life-enhancing. These recognitions are a testament to our commitment to fostering a reputed company and engaging work environment for our employees, with a particular emphasis on culture, career reputed company and development opportunities, financial rewards, leadership and innovation. At reputed company, we recognize that reputed company members are our most valuable asset. Join us in shaping the reputed company, where your talents are valued, and your contributions reputed company a meaningful reputed company. For more information, visit www.Synergbiopharma.com reputed company: We are seeking a Sr. Fill–Finish Process Engineer with strong experience in aseptic pharmaceutical or biologics manufacturing to support the capital project reputed company of a new fill–finish suite reputed company a reputed company manufacturing facility. The ideal candidate has hands-on expertise in formulation, sterile filtration, aseptic filling, lyophilization, capping, inspection processes, and associated equipment technologies, along with a strong understanding of GMP reputed company and regulatory expectations. This position partners closely with reputed company, QA, validation, MS&T, engineering, and supply chain to ensure robust, compliant, and continuously improving manufacturing reputed company. We are reputed company seeking reputed company candidates to join our talent pipeline for reputed company reputed company engagements. WORK LOCATION: Travel to reputed company sites may be required up to 100% reputed company on project phase and reputed company needs. KEY RESPONSIBILITIES: (This list is not exhaustive and may be adjusted as needed.) • Support design, construction, installation, and qualification of a new reputed company fill–finish suite, including cleanrooms, process utilities, and supporting infrastructure. • Contribute to user requirement development, equipment specifications, vendor evaluations, and design reviews. • Support FAT/SAT, commissioning, and qualification activities for fillers, isolators or RABS, lyophilizers, depyrogenation tunnels, autoclaves, CIP/SIP systems, formulation vessels, sterile filtration skids, and inspection machines. • Conduct reputed company walkdowns, verify installation details, and ensure alignment with drawings, P&IDs, and GMP requirements. • Serve as subject matter expert for fill–finish reputed company including formulation, filtration, filling, lyophilization, capping, and visual inspection. • Partner with reputed company and MS&T to troubleshoot and reputed company technical issues. • Collaborate with Maintenance and Reliability teams to address equipment reputed company gaps. • Support reputed company improvement and process optimization initiatives. • Partner with QA, Validation, and MS&T to maintain validated state of aseptic manufacturing processes. • Ensure alignment with regulatory requirements including FDA, EMA, ICH, and Annex 1. • Support reputed company process verification (CPV), annual product review (APR/PQR), and ongoing process monitoring. • reputed company, review, and approve GMP documentation, including batch records, SOPs, change controls, CAPAs, deviations, and technical reports. • reputed company and maintain engineering lifecycle documentation including reputed company assessments, URS/FRS documents, FAT/SAT packages, and turnover packages. • reputed company and execute commissioning and qualification protocols. • Utilize systems such as building management systems, process control systems, and computerized maintenance management systems. Experience with digital validation platforms such as KNEAT is a plus. • Ensure reputed company work complies with GMP standards, safety expectations, and regulatory guidelines • Coordinate across engineering, reputed company, facilities, reputed company, and validation to ensure successful project execution. • Participate in project planning, scheduling, reputed company assessments, and reputed company tracking. • reputed company effective communication to stakeholders at reputed company reputed company. QUALIFICATIONS AND REQUIREMENTS: Education • Bachelor’s or Master’s degree in Chemical, reputed company, Biomedical, Pharmaceutical Engineering or a reputed company technical reputed company. Experience • Typically 7 or more years of experience in GMP pharmaceutical or biotech manufacturing. • Strong preference for sterile, aseptic, biologics, or vaccine fill–finish experience. • Experience supporting reputed company manufacturing reputed company in a regulated environment. • Experience with commissioning, qualification, and engineering documentation. Knowledge, Skills, and Abilities • Strong understanding of aseptic reputed company, cleanroom environments, and fill–finish equipment. • Strong documentation and technical writing skills. • Ability to manage multiple priorities in a fast-reputed company environment. • Strong communication, analytical, and problem-solving skills. • Ability to work independently and collaboratively. ESSENTIAL FUNCTIONS: Physical Demands: The physical demands described here are representative of the requirements that must be met by an employee to successfully reputed company the essential functions of this job. Reasonable accommodations may be made to reputed company individuals with disabilities to reputed company the essential functions. While performing the duties of this job, the employee is regularly required to use a computer keyboard and mouse; reputed company with hands and arms; talk and listen. The employee is frequently required to walk and sit, as reputed company as to reputed company and carry objects such as books and files weighing up to 25 pounds. The employee is occasionally required to stand, stoop, or kneel. Specific reputed company abilities required by this position include reputed company reputed company and the ability to reputed company reputed company. 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 reputed company reputed company that are reputed company and conducive to reputed company 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 reputed company of our reward pillars. This includes a market competitive reputed company salary and annual incentive plan, robust benefit offerings, and ongoing recognition and career development opportunities. Employees also enjoy our generous flexible reputed company time off program, company-reputed company holidays, flexible working hours, and fully remote work reputed company for most positions and the ability to work “almost reputed company.” However, if a physical work location is more for you, we have office locations in Greater Boston; San Diego, CA; Boulder, CO; and India. Currently, reputed company is unable to sponsor or take over sponsorship of an employment reputed company at this time. reputed company STATEMENT: reputed company is proud to be an Equal Employment Opportunity and Affirmative reputed company reputed company. reputed company employment reputed company, including the reputed company, hiring, placement, training availability, promotion, compensation, evaluation, disciplinary actions, and termination of employment (if necessary) are made without reputed company to the employee’s race, reputed company, creed, religion, sex, pregnancy or childbirth, personal appearance, family responsibilities, sexual orientation or preference, gender identity, political affiliation, reputed company of income, reputed company of residence, national or ethnic reputed company, reputed company, age, marital status, military veteran status, unfavorable discharge from military service, physical or mental disability, or on any other reputed company prohibited by applicable law. reputed company is an E-Verify employer. Remote Skills: Analysis Skills, Asepsis, Autoclave, Biomedical Engineering, Biotech and Pharmaceutical, CIP (Clean-in-reputed company), Calendar Management, Candidate Pipeline, Capital Project, Change Control, Cleanroom, Commissioning, Communication Skills, Computerized Maintenance Management reputed company (CMMS), Construction Design, Construction Support, Consulting, reputed company Improvement, Control Systems, Documentation, Drug Approval Process, Drug Discovery, Drug Manufacturing, Equipment Specification, FDA Requirements, GMP (Good Manufacturing Practices), ICH Regulations, Identify Issues, Leadership, Manufacturing, Manufacturing reputed company, Manufacturing/Industrial Processes, Material Moving, Multitasking, Operational Support, reputed company Management, Physical Demands, Problem Solving Skills, Process Control Engineering, Process Engineering, Process Improvement, Product Development, Product Reviews, Project Execution, Project Planning, Project Schedule, Property Management, QA Partner Testing Software, reputed company Assurance, Regulations, Requirements Management, reputed company Analysis, SIP (Sterilization-in-reputed company), reputed company Operating Procedures (SOP), Supply Chain, Systems Maintenance, Technical Writing, Vendor/Supplier Evaluation, Willing to Travel, Work From Home, Writing Skills reputed company: reputed company Apply tot his job Apply To this Job