Pharmaceutical Engineering Line Lead / Supervisor

Management Recruiters of Edison; Spokane (WA); On-site; USD 150,000 - 170,000; Full time

Job summary

Management Recruiters of Edison is seeking an Engineering Line Lead/Supervisor for a BioPharma CDMO in Spokane, WA. The role provides technical leadership for one complete filling line and supervises up to three engineers.

You will manage capital projects, ensure cGMP and regulatory compliance, and coordinate engineering activities with the Plant Engineering group. Overnight travel is about 10%, relocation assistance is offered, and compensation reaches up to $165K+ plus a 10% bonus.

Qualifications

• Bachelor's degree in Engineering or related technical field.
• Minimum 5+ years engineering experience.
• 3+ years in BioPharma industry.
• 2+ years project engineering/management.
• Demonstrated leadership or supervisory experience.
• Experience in facility or manufacturing engineering and GMP environments.

Responsibilities

• Provide technical oversight and leadership to the engineering team within the CMO unit.
• Drive technical improvements and responses to equipment and facility observations.
• Manage capital project schedules and budgets.
• Assign and oversee engineering projects including internal capital, compliance, and contract manufacturing.
• Coordinate and supervise engineering resources for staffing on current and upcoming projects.
• Ensure area, equipment and infrastructures comply with regulatory agencies.
• Execute high level projects from conception aligned with management objectives.
• Manage facility and equipment updates to meet growth and objectives.
• Support client audits and technical visits.
• Communicate project status and risks to upper management.

Skills

Engineering leadership

Project management

Supervisory experience

Regulatory compliance

MS Office proficiency

Education

Bachelor's degree in Engineering

Tools

MS Project

AutoCAD

SAP ERP

Job description

Our client – a global and growing BioPharma CDMO company needs an Engineering Supervisor - Line Lead with Pharmaceutical Industry experience at their expanding plant in WA state, Excellent total comp. up to $180K+ with excellent Benefits + Relocation Package.

Job Posting # 2723R

Job Title: Pharmaceutical Engineering Line Lead / Supervisor Overnight Travel: 10%

Location: Spokane, WA

Relocation: YES – Theclient offers a generous package for relo assistance.

Compensation: Salary range up to $165K+ Annual Bonus (10 %)

Full Benefits: Medical, Vision, Dental, 15 days’ vacation/Sick time, 10 - Holidays, 401k (match up to 4%)).

Company Info:

Our client is a growing CDMO company in the Pharmaceutical Industry. They are a part of a global parent company with sites in many countries with around 1,300 people at this site in Spokane, WA.

This is an integrated contract development and manufacturing organization (CDMO) offering specialized Aseptic Sterile manufacturing, filling and lyophilization of drug products in Vials.

Group Info:

Be part of the Plant Engineering group of around 60 technical people. This role will be responsible for the technical aspects of 1 of the 4 lines

This role will report to the Engineering Director.

Note 1:

The company recently completed their 3rd state-of-the-art Sterile Liquid compounding & Vial Filling line and are currently expanding again with a 4th line at this growing plant site.

Note 2:

The primary focus will be the technical and project engineering aspects of 1 complete filling line. This person will lead and supervise up to 3 Engineers.

Note 3:

Client will support transfer of existing H1B Visa for this permanent direct hire role, but will not sponsor for a new H1B visa.

Job Summary:

The Engineering Line Lead position provides leadership, manufacturing support and coordination of the engineering department for the CMO line specific projects.

This position ensures that contract projects, equipment functionality, compliance support, and capital expenditures are executed per Company management initiatives, compliance guidelines, the project management system, and the capital budget schedule.

It is the responsibility of this position to ensure line specific compliance of the CMO equipment and team with state, local, and federal regulations.

This position ensures operations and projects are carried out under adherence to GEPs and cGMPs.

Job Functions and Responsibilities in cGMP settings.

• Provide technical oversight and leadership to the engineering team roles responsible for their area of responsibility within the CMO Business Unit.
• Drive technical improvements and internal/external responses to equipment and facility observations.
• Management of the assigned capital project schedules and budgets.
• Assign and oversee engineering projects including internal capital, compliance, and contract manufacturing.
• Coordinate and supervise engineering resources to ensure adequate and appropriate staffing for current and upcoming projects.
• Ensure designated area, equipment and engineering infrastructures are compliant to local, state, federal, and international regulatory agencies.
• Execute high level projects from conception, consistent with upper management objectives for business growth.
• Manage and execute facility and equipment updates to meet company growth and economic objectives.
• Support client audits and technical visits.
• Effectively communicate project status, constraints and current or potential issues to upper management.

Candidate Must Have:

• Bachelors of Science in Engineering or related technical degree.
• 5+ years of Engineering Experience
• 3+ years of Engineering experience in the BioPharma industry
• 2+ years of Project Engineering/Management experience
• Some Leadership, Supervisory experience over Jr. Engineers, Technicians.
• Facility or Manufacturing Engineering Experience
• MS Office suite (Word, PowerPoint, Excel) experience

Candidate Nice to Have:

• BS in Mechanical, Chemical, Electrical, Manufacturing engineering
• Advanced degree or PE or PMP certification
• Experience with PM Software – MS Project, Design software - AutoCAD & ERP – SAP
• Experience with Pharma sterile aseptic manufacturing, filling, Lyophilization
• Interfacing with OEM equipment vendors, Construction/consulting partners

Keywords: Projects, Plant Project, engineering, Pharma, CDMO, manufacturing, plant, FDA, GMP, Sterile Aseptic liquid filling, Isolators, Clean rooms, Lyophilization, contract Manufacturing, Supervisor, Lead