Engineer, Technical Services - 1st Shift

Key responsibilities

• Provide product stewardship by developing subject matter expertise for products and processes.
• Utilize this subject matter expertise to advance process/product quality, safety, supply, cost of goods, and general continuous improvements.
• Conduct complex investigations and provide technical evaluations for unplanned manufacturing events, with some support from Technical Services staff.
• Provide Technical Services troubleshooting and complete process improvement projects resulting from those findings.
• Lead cross-functional teams and develop detailed timelines for projects.
• Follow up on open actions, publish reports, and escalate when obstacles/challenges arise.
• Interface frequently with other departments to lead completion of assigned projects and occasionally represent Tech Services as a team member on sitewide projects.
• Design functional requirements, risk assessments, protocol generation and execution for process, products and equipment.
• Document all work appropriately in a cGMP environment.
• Prepare presentations for project updates.
• Will include the use of laboratory notebooks, meeting summaries, project status updates, protocols and reports.
• Interact with vendor and outside contractors/consultants as needed.
• Support project/trial financial estimates, annual budget and forecast duties.
• Provide off-shift/weekend support to Operations as necessary.
• Provide technical support to regulatory and management staff for MPD pharmaceutical components.

Minimum qualifications

• Engineering Bachelor's degree (or equivalent) and 5 years of pharmaceutical experience is required.
• A combination of experience and/or education will be taken into consideration.
• Must possess strong technical knowledge and the ability to think critically.
• Must have troubleshooting skills and have solid communication and writing skills.
• Must possess computer skills and knowledge of Microsoft Excel, Word, Access, PowerPoint, and Outlook.
• Preference given to knowledge of statistical software programs (MiniTab).

Pay

The salary range for this position is $66,000.00 - $127,000.00 USD.