Process Engineer I, New Jersey

Perspective Therapeutics; New Jersey; Hybrid; USD 90,000 - 140,000; Full time

Benefits offered by this job

Comprehensive benefits package

Medical insurance

401k with company match

401k with company match

Short & long-term disability

Job summary

A biotech company is seeking a Process Engineer to provide technical support in GMP drug product manufacturing. This hybrid role in Somerset, NJ requires technical problem-solving, communication skills, and a Bachelor's degree in Engineering, with at least 2 years of experience in the pharmaceutical industry. A comprehensive benefits package is offered.

Qualifications

• Minimum 2+ years of experience in pharmaceutical or medical device manufacturing.
• Direct experience with technical transfer and validation methodologies.
• Familiarity with regulatory guidelines (CFR parts 210 and 211).
• Excellent written, verbal and presentation skills; able to communicate with all management levels.
• Self-starter; able to work independently and in a team.
• Demonstrated technical problem-solving with root cause analysis tools.
• Direct experience with project management.
• Excellent organizational and time management skills.
• Strong inter-departmental relationships; capable technical resource.
• Direct experience with technical transfer and aseptic/parenteral pharmaceutical process validation methodologies.
• Familiar with CFR parts 210 and 211 and supporting regulatory inspections.
• Experience drafting/reviewing Chemistry, Manufacturing and Controls (CMC) regulatory filing sections.
• Exposure to radiation hazards.
• Ability to travel 10 to 15%.

Responsibilities

• Provide technical support for GMP drug product manufacturing.
• Conduct investigations into product/process quality events.
• Lead root-cause analysis investigations and corrective actions.
• Write and execute validation protocols with/without study director role.
• Lead investigations and root-cause analyses for corrective actions.
• Support drafting of CMC sections and regulatory submissions.
• Develop training materials and conduct sessions on document updates.
• Present data as SME to regulatory agencies.

Skills

Technical problem-solving skills

Project management skills

Communication skills

Organizational skills

Teamwork

MS Office proficiency

Problem solving

Quality systems

Education

Bachelor’s Degree in Engineering or related scientific discipline

Tools

MS Office suite

Job description

Join a great team that is working to target cancer from the inside out! The Process Engineer will provide technical support for GMP drug product manufacturing operations. This role will provide technical support and conduct investigations into product/process quality events and customer complaints; identify, assess, and execute projects to optimize existing processes, raw materials, components, and packaging in manufacturing and final product packaging; work with multi-functional teams to execute and deliver assigned projects, including specification, conceptual development, protocol writing, selection, testing, and qualification. This is a hybrid role, based part-time in the office and part-time remote, with the office located in Somerset, NJ.

Essential Functions

• Identify opportunities to improve quality, efficiency, and customer service through changes to product components, component processing, and component inspection. Evaluate those opportunities and present projects to management for approval to implement changes.
• Work with multi-functional teams to execute product and packaging projects to improve and optimize manufacturing and packaging processes. Support complex projects to meet established timelines without impacting manufacturing. Proactively adjust schedules to meet changing priorities.
• Provide technical support for the transfer of new or improved manufacturing processes between functional groups or sites, ensuring knowledge capture and compliance with quality and regulatory standards.
• Write and execute validation protocols either acting as the study director/validation engineer or working with the Validation department.
• Lead and participate in investigations to drive technically and scientifically sound corrective and preventative actions. Apply creative problem-solving techniques using knowledge base and historical experience to address immediate, short-term, and future needs. Lead root-cause analysis investigations as a technical resource.
• Investigate product complaints and write reports of investigations. Assist as required to support conclusion and possible corrective actions.
• Provide support in the development, review, and maintenance of various radiopharmaceutical and cGMP documents, including Standard Operating Procedures (SOPs), Batch Records, Work Instructions and technical documents.
• Assist in the development of training materials and conduct training sessions for target audience on document updates, providing clarity and guidance, ensuring full compliance.
• Present data and information as a technical subject matter expert to regulatory agencies.
• Actively promote safety. Always demonstrate good safety practices including the appropriate use of protective equipment. Report and take initiative to correct safety & environmental hazards.
• Write and manage actions for change controls in Quality Management System (QMS) as applicable for tech transfers.
• Stay up to date with industry regulations and guidelines (e.g., FDA, EMA) to ensure that all documentation meets regulatory requirements and contributes to regulatory submissions.

Qualifications

• Bachelor’s Degree in Engineering or related scientific discipline with a minimum 2+ years of experience in pharmaceutical or medical device manufacturing or other related regulated industry.
• Expert knowledge of MS Office suite.
• Previous experience working with radiopharmaceuticals and CMOs strongly preferred.
• Must possess excellent written, verbal and presentation skills. Must be able to communicate effectively with all levels of management, both internal and external.
• Self‑starter with the ability to work well both independently and in a team environment.
• Demonstrated technical problem‑solving skills with root cause analysis tools.
• Direct experience with project management skills.
• Excellent organizational and time management skills.
• Establishes strong inter‑departmental relationships and is viewed as a valuable technical resource to others.
• Direct experience with technical transfer and aseptic/parenteral pharmaceutical process validation methodologies.
• Familiar with Code of Federal Regulations (CFR) parts 210 and 211 and supporting regulatory inspections.
• Experience in drafting and reviewing Chemistry, Manufacturing and Controls (CMC) regulatory filing sections.
• During this job, the employee may encounter exposure to radiation hazards.
• Ability to support travel 10 to 15%.

Benefits

We offer a comprehensive benefits package including medical, dental, vision, FSA, life insurance short & long-term disability insurance, and a 401k with a company match.

Equal Employment Opportunity

Perspective Therapeutics provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.