8410 Packaging Engineer I
Objectives & Scope of the position:
This position supports the establishment of a world-class packaging organization by providing technical expertise in the development and deployment of new packaging systems for pharmaceutical products and combination products.
The selected candidate will work on a variety of packaging initiatives and will support Global Packaging Development in establishing packaging systems for clinical and commercial use.
Job Responsibilities:
Develop and qualify global primary and secondary packaging solutions for sterile, non-sterile and combination products, incl. author/co-author the related packaging specifications and qualification documentation.
Qualification of global packaging solutions in line with the current validation requirements (e.g. Development of test protocols and reports, risk assessment, execute IQ/OQ/PQ, and shipping qualification).
Maintenance of global packaging solutions (e.g. support change control records, provide impact assessments, execute requalification).
Evaluate and develop new materials and/or alternate packaging materials, packaging solutions or packaging systems based on product, regulatory, business or technical requirements.
Support or lead projects delivering innovative packaging technologies and systems under the company’s global packaging technology centers.
Education & Qualifications:
Personal Requirements:
Bachelor degree, preferably with an engineering degree in packaging, materials science, or a related field.
At least 1 year working experience in relevant field.
Proficient technical leadership, collaboration and communication skills.
English language proficiency required.
Technical Requirements:
Knowledge of packaging testing methodologies and standards including, shock, drop and vibration testing, peel force and tensile testing, barrier analysis, CCI/Sterile integrity, DIN, ISO, ISTA, USP, FDA, MHRA and ASTM standards for packaging design and validation.
Knowledge of packaging process equipment, related to steriles, and non-steriles, and combination products packaging activities (e.g. vials, PFS, devices, aseptic form/fill/seal, blister and bottle filling lines), printing systems and serialization.
Knowledge on equipment IQ, OQ, and PQ and development of qualification protocols / reports for packaging and shipping qualification activities.
Knowledge of design control for combination products.
Working knowledge of computer systems including TOPS, CAD or Solidworks, and Microsoft tools including MS project, and Adobe.
Knowledge of industry best practices and technical writing skills such as GMP and GDP.
The hiring range for this position is $35-$41 per hour. The base pay actually offered will take into account internal equity, and may also vary depending on candidate’s geographic region, job-related knowledge, skills, and experience amongst other factors
Harvest Technical Services is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, Sexual orientation, national origin, genetics, pregnancy, disability, age, veteran status, or any other federal, state, or local protected class.