PharmEng Technology has been providing quality services to leading manufacturers of healthcare and pharmaceutical products since 1997. Our specialists hold expertise in Commissioning & Qualification, Validation, Quality Systems, Regulatory Affairs, Engineering, and Training to ensure that our clients can keep on providing the world with their cost-effective and high-standard healthcare products.

At PharmEng Technology, we strive to cultivate the best working environment where empowerment, passion and perseverance are nurtured while serving our clients to achieve their unique business goals. We are seeking an experienced Technology Transfer Scientist for Indianapolis, IN.

Act as a liaison between our clients, Process Development (PD), and Operations teams. A successful candidate will work closely with Project Managers and PD team to ensure new processes are transferred from clients and to Operations with emphasis on scalability, transferability, and robustness. The candidate will serve as the process lead to ensure effective and efficient tech transfer and must exhibit strong initiative, cross-functional leadership, and effective communication.

SUPERVISORY RESPONSIBILITY

This role has the potential to supervise the following positions:

Direct:

Technical Writer(s)

Indirect:

Train PD employees on a wide variety of written procedures, including batch records and operating procedures

ESSENTIAL JOB FUNCTIONS/DUTIES

• Ensure overall project success, identifying and tracking progress against key project milestones
• Serve as the Tech Transfer point of contact with clients for various projects
• Manage team of technical writers
• Actively lead and manage knowledge transfer activities between clients and process development team
• Collaborate with operations and testing lab to complete transfer and validation programs
• Ensure clear commitment and alignment between cross functional technical teams
• Maintain organized project resources for drafting production procedures, Quality Control (QC) processes, and materials specifications
• Work with clients to identify and mitigate risks to manufacturing in early phase of the new product development process
• Provide all necessary information to the technical writing team for generation of master batch records
• Review master batch records for accuracy to ensure successful process transfer
• Deliver comprehensive technical transfer reports to clients and for internal use
• Author, utilize, and train employees on a wide variety of written procedures, including batch records and operating procedures
• Support regulatory filings and justifications as a member of the technical regulatory response team
• Provide post-launch manufacturing/QC support
• Ensure safe working environment and compliance with OSHA, EHS, Quality, and cGMP procedures and policies by your direct reports

EDUCATION / CERTIFICATIONS / LICENSES

Essential/Desired

BS degree in Biology, Biochemistry, Molecular Biology, or similar field

Essential

Knowledge in process validation, equipment qualification, and aseptic process equipment requirements

Why PharmEng Technology?

Our consultants come from different areas of the Pharmaceutical/Biotech/Medical Device industries and have extensive experiences obtained from world-class organizations in North America, Europe, and Asia. At PharmEng Technology, we value everyone’s unique talents and work together to support our clients. We offer continuous career growth, competitive wages, opportunities for travel and a team mentality that sets us apart from our competitors. It is the growth of our staff that continues to grow our company globally.

What We Have:

Comprehensive benefits package & competitive wages

A supportive environment where employee growth is promoted

PTO & paid holidays

Company Response to Covid-19

While we serve industries deemed essential businesses, PharmEng Technology will follow safe business practices and adhere to local, state, and federal guidelines. When possible, PharmEng Technology will allow remote work from home.

EEOC Statement

At PharmEng Technology, we don’t just accept difference — we celebrate it, we support it, and we thrive on it for the benefit of our employees, our clients, and our community. PharmEng Technology is proud to be an equal opportunity workplace.