Process Engineer/Scientist

Process Engineer/Scientist

Process Engineers/Scientists report to the Senior Manager of Technical Services. They act as a Subject Matter Expert for pharmaceutical manufacturing processes including technical transfer, leading, planning, and execution of technology and process innovation that aligns with the Strategic Plan. They exemplify appropriate industry standards (cGMP/GDP). Projects and initiatives may vary, and include things such as: authoring and executing protocols and reports to support engineering studies or validation activities; new product/process introduction, process re-design, and process improvement projects; project management; manufacturing troubleshooting; investigating deviations and executing corrective and preventive actions; etc. Candidate’s experience and skillset will determine position level (I, II, or III).

Why Join Leiters Health?

Are you passionate about making a real impact in the pharmaceutical industry? Do you thrive in a collaborative, innovative environment where your skills and ideas are valued? Look no further – Leiters Health is seeking talented individuals like you to join our dynamic team!

At Leiters Health, we're not just another pharmaceutical company – we're pioneers in the field, dedicated to delivering high-quality compounded sterile products and outsourced solutions to healthcare providers nationwide. Our commitment to excellence and patient safety is at the core of everything we do.

• Innovative Culture: Be part of a forward-thinking company that encourages creativity, welcomes fresh ideas, and fosters an environment of continuous improvement.
• Meaningful Work: Contribute to a purpose-driven organization dedicated to providing critical medications and healthcare solutions that positively impact patients' lives.
• Professional Development: Access ongoing training, mentorship, and growth opportunities to expand your skills and advance your career within a rapidly growing industry.
• Cutting-Edge Technology: Work with state-of-the-art facilities and advanced technologies, staying ahead of the curve in pharmaceutical manufacturing.
• Collaborative Environment: Join a team of passionate individuals who are dedicated to teamwork, support, and mutual success, fostering a culture of inclusivity and collaboration.

Who We're Looking For:

We're seeking enthusiastic individuals who are driven, adaptable, and passionate about contributing to a mission-driven organization. Whether you're an experienced professional or just starting your career, Leiters Health provides an environment where your skills and talents will be recognized and appreciated. Sound like you? Apply today!

Essential Functions:

• Acts as a Subject Matter Expert for manufacturing processes including formulations, extractions, aseptic filling, visual inspection, labeling, packaging, specific product lines, and equipment.
• Owns many critical tasks, balancing workload, completing them in a timely fashion, collaborating within cross-functional projects such as new product introductions, process re-design, and process improvements.
• Communicates to project leads, project team, and direct management about scope, schedule, and resourcing.
• Authors and reviews technical documents for cross-functional audiences, adhering to cGMP/GDP regulatory expectations, including but not limited to Batch Records, Change Controls, Standard Operating Procedures (SOPs), deviation investigations, Corrective and Preventive Actions (CAPAs), and Risk Assessments.
• Designs, writes, and executes engineering studies using robust statistical analysis. Collects production data and applies standard scientific and statistical methods to analyze, document, and diagram production processes. Analyzes and documents results in reports.
• Assists more senior team members with validation and qualification activities (examples may include writing protocols for non-complex equipment and processes, executing protocols in part or in whole, and writing reports).
• Supports response to urgent and critical issues that impact production and/or compliance, acting as a first line of response, investigating issues, troubleshooting processes and equipment, and driving to solutions, both in an interim and long-term basis.

Supervisory Responsibilities:

• None

Experience and Necessary Skills:

• Bachelor’s degree in the sciences required; i.e. chemical engineering, chemistry, or relevant industry experience.
• Relevant experience and skillset will determine position level (I, II, or III). Recommendation is 0+ years for I. Experience considered includes job responsibilities with a regulated industry (especially Pharmaceutical or Medical Device GxP environment), Project Management, Equipment or Process Validation, and/or statistical analysis using software (JMP, MiniTab, Saas, etc.)
• Strong curiosity and willingness to learn, along with the tenacity and drive to see projects through.
• Willingness to support tasks outside normal job description, as needed. Can-do attitude!
• Advanced computer skills including proficiency in Microsoft Office (Word, Excel, Power Point).
• Strong verbal and written communication skills with ability to communicate at all levels of the organization.
• Ability to create technical and professional documents.
• Strong attention to detail and accuracy.
• Ability to multi-task, with strong organization and time-management.
• Ability to work under pressure and independently with the ability to make decisions according to established guidelines and accomplish tasks accurately and on a timely basis.

Benefits:

• 100% employer paid medical plan.
• Dental & Vision insurance options including FSA & HSA
• Employer Paid Life Insurance & Employee Assistance Program
• Short Term & Long-Term Disability Insurance
• Up to 4% 401K Matching (100% vested on day one!)
• Generous Paid Time Off Options – vacation, sick, paid leave and holidays!
• $5,250 Annual Tuition Reimbursement after 6 months
• $1,000 Referral Bonus Program with no limit
• Eligible for annual bonus program

Timeline: We will be accepting applications on and ongoing basis until position is filled.

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law.

*Please note that we do not work with third-party recruiters or agencies for this position. If you are a qualified candidate and wish to apply for this job, please do so directly through our official application process. We appreciate your understanding and cooperation in this matter.