Principal Process Engineer

PerkinElmer•Collegeville, PA

1d•Onsite

About The Position

When joining PerkinElmer, you select an experienced and trusted leader in scientific solutions, with the support of a global service network and distribution centers, providing the right solution, at the right time, to meet critical customer needs. With over an 80+ year legacy of advancing science and a mission of innovating for a healthier world, our dedicated team collaborates closely with commercial, government, academic and healthcare customers to deliver our broad portfolio of analytical solutions, and OneSource services. We are seeking a highly motivated and ambitious candidate to join the PerkinElmer OneSource Scientific Services team based at one of our customer sites in Collegeville, PA. The successful candidate will be working within the PerkinElmer Technical Lab Services (TLS) division and will be placed within a research unit at the customer site who have a focus on process engineering and modeling, supporting R&D and manufacturing activities and are at the forefront of developing innovative and life-changing medicines for patients. The candidate will work within a collaborative team environment across a diverse biotherapeutic portfolio within the company and can develop in PerkinElmer’s scientific arena. The role will report to the PerkinElmer Regional TLS Leader and will be based at the GSK Upper Providence campus.

Requirements

Strong communication and interpersonal skills, both written and verbal.
Self-motivated and able to work under pressure to prioritize conflicting deadlines.
An ability to meet timelines successfully with the utmost attention to detail while setting high performance standards.
Service orientated attitude combined with innovative thinking.
Strong interpersonal skills; strong team player with customer satisfaction focus
Ability to execute new and established methods and protocols.
Ability to understand, interpret, and communicate complex scientific data.
Understanding of standard software packages (i.e. Microsoft Office).
Ability to operate within company and/or customer site safety codes of practice and adhere to data integrity principles.
PhD in Pharmaceutical Sciences, Biotechnology, Chemistry, Biology, Physics, Chemical Engineering, mechanical engineering or any engineering field. Experience in Freeze Drying/Lyophilization highly desired.
OR MS with 3+ years’ experience in Pharmaceutical Sciences, Biotechnology, Chemistry, Biology, Physics, Chemical Engineering, mechanical engineering or any engineering field. Experience in Freeze Drying/Lyophilization highly desired.
OR BS with 5+ years’ experience in Pharmaceutical Sciences, Biotechnology, Chemistry, Biology, Physics, Chemical Engineering, mechanical engineering or any engineering field. Experience in Freeze Drying/Lyophilization highly desired.

Nice To Haves

Expertise in process development optimization, specifically lyophilized drug product manufacturing processes.
Publications in peer-reviewed journals.
Experience in Steriles drug product process development, PAT, characterization, scale -up and technology transfer, and modelling.
Experience in the application of state-of-the-art laboratory equipment, equipment automation, data automation, PAT tools and modelling software.
Experience evaluating, developing, and qualifying manufacturing equipment.
Proven ability to lead collaboratively in a matrix-style environment.
Knowledge of GCP, GCLP, GMP, and data integrity principles in the pharmaceutical environment.
Knowledge of 5S and/or 6 sigma principles is a plus.

Responsibilities

Conduct laboratory experimentation and analytical testing of putative formulations & drug products, and combination assessment in collaboration with device engineering.
Work on developing processes for lyophilized drug product dosage forms and other Steriles process development.
Platform development workstreams to assess, develop and implement new manufacturing platforms.
Drug Product technology transfer activities and reports as appropriate for transfer/scale-up to the manufacturing site (internal or external).
Preparation and review of developmental and manufacturing batch records, SOPs, and regulatory documentation as appropriate.
Automate developmental work packages and establish control strategies through the development and maintenance of system modeling platforms.
Make innovative contributions to the department by leading platform development workstreams to assess, develop and implement new manufacturing/PAT platforms, for example lyophilization.
Be an expert and be accountable for manufacturing/PAT platform robustness across the portfolio.
Author reports relevant to Process Engineering and analytics platforms.
Track assay performance metrics and communicate issues and suggest improvements to current assay methodology, supporting evaluation of new technologies where applicable.
Comply with Health and Safety procedures for own well-being and quality of product.
Actively seek opportunities to develop the service by discussion with the team leader and customer or by sharing the best practice with other groups.
Act as an ambassador for TLS and promote PerkinElmer’s core values.
Operate to approved quality standards.
Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities of this job at any time.