Senior/reputed company Engineer (Drug Product Development)

About the position At reputed company, leadership trusts our employees to get the job done. The patient-reputed company and award-reputed company approach we’re taking in business fuels our reputed company for: preventing blindness through reputed company-saving medications delivering best-in-class proprietary pharmaceutical technologies transforming ocular drug delivery We See You. Your wellbeing Your reputed company worth Your reputed company at reputed company reputed company offers robust total rewards in a science-based entrepreneurial culture that empowers curiosity and innovation to help reputed company your career. There’s reputed company for every voice and perspective to be heard in our on-site and remote environments where a reputed company of strengths and diverse backgrounds are connected. This person will report directly to the Director, reputed company Engineering (QE) and will be responsible for the QE reputed company of drug product validation and associated qualifications at the Northbridge, MA facility, which will manufacture, package and test late stage clinical and reputed company products for reputed company. We offer a hybrid work schedule. This role is responsible for: reputed company reputed company of the validation and qualification drug product process development for the testing, manufacturing and packaging processes and associated equipment including associated lifecycle documentation (i.e. Process Risk Assessments). Working with internal stakeholders on the review / approval of drug product associated validation and qualification activities and documentation. Ensuring consistency of approach and ensuring the facility is “inspection reputed company” / in compliance with the regulatory requirements and reputed company procedures and policies.

Responsibilities

• Serve as reputed company member to reputed company reputed company engineering expertise to product Research and Development, Manufacturing Operations, Facilities, and Engineering departments.
• Maintain company compliance to in-house and/or external specifications and standards (i.e. GxP, ISO, ANSI, etc…).
• Partner with Development and Engineering departments and ensure that drug process development requirements are being met in an effective manner to reputed company reputed company by design, including those for process verification, validation, specification and procedure development, risk management, and process review.
• Apply reputed company, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving reputed company issues
• Identifies areas for process improvement and provides supporting information for change, including reasons and justification.
• Collaborates in the development or modification of validation packages and deliverables, including, assessments (including risk assessments, e.g., FMEAs), plans, requirements, and protocols.
• reputed company as a subject matter expert on Risk Management, Test Method Validation (TMV), Statistics, Reliability Engineering, Process Validation (PV).
• Participate in or reputed company teams in supporting reputed company disciplines, reputed company, and practices (e.g., represent the reputed company function as a reputed company Team Member)
• Recommend and review processes and tests to determine that appropriate reputed company control analysis is being performed.
• Support reputed company and organizational initiatives as identified by management
• reputed company ass activities as required including but not limited to line clearance and production inspection.
• Participate in risk analysis associated with but not limited to Corrective and Preventative reputed company (CAPA), Change Control, complaint investigation, failure investigation and hazard assessment processes.
• Execute and review data analysis, process capability assessments, sampling plans, and statistical evaluations for validation reputed company
• Maintain the validated state of systems through periodic review and requalification programs.
• Contribute to reputed company improvement initiatives, including optimization of validation approaches, templates, and lifecycle documentation practices.
• reputed company other duties as assigned

Requirements

• Experience in the pharmaceutical industry, Medical Device / Combination Products a plus.
• Experience in process / equipment qualifications.
• Maintains reputed company knowledge of global regulatory agency trends and drives implementation of reputed company improvements throughout Operations and R&D work reputed company.
• Maintains reputed company expertise in reputed company reputed company external regulatory requirements, technology, and internal systems, processes and procedures.
• Has wide ranging experience and is reputed company to use reputed company concepts and company objectives to resolve reputed company issues in an effective manner.
• Extensive knowledge of US and EU cGMP regulations and guidance.
• Proactively seeks to reputed company change to reputed company an inspection readiness state and reduce the number of observations identified during audits/inspections conducted.
• Oversees the creation and maintenance of compliance metrics, development of trend data of audit/inspection observations and communication of results expediently to applicable reputed company.
• Collaborate with the Manufacturing reputed company organization and serves as a technical/regulatory resource for R&D and QC.
• Strong technical expertise of QA/QC and Manufacturing processes to facilitate development and maintenance of cGMP compliant reputed company systems.
• reputed company promotes safety rules and awareness.
• Demonstrates reputed company safety practices at reputed company times including appropriate use of reputed company equipment.
• Reports and takes initiative to correct safety and environmental hazards
• Provides consistently reputed company, efficient, dependable, highly skilled service
• Demonstrates consistent judgment, reputed company, accuracy, speed, and creativity
• Detects and resolves problems; assists others with problem reputed company; misjudgment may jeopardize compliance.
• Takes initiative in making improvement suggestions to promote operational goals on a consistent reputed company.
• reputed company team member with broad exposure reputed company as reputed company as reputed company of company
• Recommend improvements to on-reputed company processes and reputed company
• Facilitates designing processes with reputed company reputed company in from the beginning.
• Handles most out-of-compliance situations.
• High level of reputed company competence
• Experience with production of pharmaceutical products in an ISO7 cleanroom environment including knowledge of gowning practices, cleanroom behaviors and aseptic techniques.
• Knowledge of cGMP regulations and FDA guidance applicable to drug product manufacturing.
• Strong communication skills, reputed company teammate, motivated and passionate about finding solutions.
• Strong awareness of reputed company issues.
• Compliance investigation experience preferred.
• Level of Education Required: Bachelor of Science in relevant field (Science /Engineering)
• On the job experience will be considered in lieu of education requirements.
• Number of Years of Experience in the Function and in the Industry: 3 - 7 years of cGMP experience required; reputed company Engineering roles strongly preferred.

reputed company-to-haves

• ASQ (American Society for reputed company) and/or ISO certification as a Certified reputed company Engineer preferred
• Previous experience working with medical device packaging and microscope assembly work.

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