Engineering Jobs in Westfield

Aseptic Fill/Finish | Liquid Drug Product

Weekend Day Shift -> Friday - Sunday from 6am to 6pm (2 openings)

Weekend Night Shift -> Friday - Sunday from 6pm to 6am (2 openings)

Full-time, Direct Hire with Full Benefits

A pharmaceutical manufacturing organization is seeking a Formulation Specialist to support bulk drug product preparation within an aseptic sterile fill/finish environment. This hands-on role is responsible for formulation, equipment operation, and cGMP manufacturing activities supporting aseptic production.

The position works closely with manufacturing, quality, and technical teams to ensure safe, compliant, and efficient batch execution while contributing to process improvements and operational excellence.

Key Responsibilities

• Perform weighing, dispensing, and formulation activities for liquid drug product manufacturing
• Set up, operate, clean, and maintain formulation and processing equipment
• Execute manufacturing operations within controlled and cleanroom environments
• Complete batch documentation and manufacturing records in accordance with cGMP requirements
• Support aseptic filling operations and equipment preparation as needed
• Assist with validation runs, engineering batches, and process troubleshooting
• Train and support team members on manufacturing procedures and best practices
• Participate in continuous improvement and equipment optimization initiatives
• Collaborate cross-functionally to ensure production timelines and quality standards are met

Basic Qualifications

• High school diploma or equivalent required
• Minimum 1+ year of GMP pharmaceutical manufacturing experience or 3+ years of related manufacturing experience
• Experience operating and maintaining production equipment in a regulated environment
• Basic computer proficiency (Microsoft Office and similar systems)

Preferred Background

• Bachelor's Degree with a Scientific focus (not required)
• Experience in sterile or aseptic pharmaceutical manufacturing environments
• Knowledge of cGMP regulations and good documentation practices
• Familiarity with SAP/ERP or inventory management systems
• Strong communication skills and attention to detail

Work Environment

• Pharmaceutical manufacturing facility supporting sterile drug product production
• Cleanroom and controlled manufacturing areas required (Grade A and Grade C)
• Hands-on production role with weekend schedule coverage

Aseptic Fill/Finish | Pharmaceutical Manufacturing | Sterile Injectables

Weekend Day Shift -> Friday - Sunday from 6am to 6pm (10% Shift Differential) (2 openings)

Weekend Night Shift -> Friday - Sunday from 6pm to 6am (15% Shift Differential) (2 openings)

Full-Time, Direct Hire with Full Benefits

A pharmaceutical manufacturing organization is seeking an Equipment Specialist to support sterile drug product manufacturing operations. This hands-on role is responsible for operating, troubleshooting, and maintaining production equipment used in aseptic fill/finish processes. This individual will play a key role in supporting manufacturing operations by ensuring equipment is properly prepared, operating efficiently, and meeting GMP quality standards. The position will also assist with equipment improvements, troubleshooting, and technical support for the production team.

Key Responsibilities

• Set up, operate, and perform changeovers on pharmaceutical production equipment (changeovers are a requirement)
• Support batch start-up activities and execution of manufacturing cycles
• Perform work within controlled manufacturing environments including cleanrooms (Grade A and Grade C)
• Execute aseptic operations within isolator systems when required
• Document manufacturing activities and complete batch records in accordance with cGMP requirements
• Assist with equipment troubleshooting, repairs, and preventative maintenance
• Support validation runs, engineering batches, and equipment qualification activities
• Serve as a technical resource for filling equipment and related manufacturing systems
• Train manufacturing staff on equipment operation and production procedures
• Participate in process improvements and equipment optimization initiatives
• Work with engineering, operations, and quality teams to resolve production issues and maintain operational efficiency

Basic Qualifications

• High school diploma or equivalent required
• Approximately 7+ years of experience working with GMP pharmaceutical manufacturing equipment
• Hands-on experience installing, operating, cleaning, and maintaining production equipment in a regulated environment
• Strong mechanical aptitude and troubleshooting abilities
• Proficiency with basic computer systems (Microsoft Office or similar tools)

Preferred Background

• Bachelor’s Degree in a Science related discipline
• Experience supporting aseptic or sterile injectable fill/finish manufacturing processes
• Working knowledge of cGMP standards and pharmaceutical manufacturing operations
• Familiarity with SAP/ERP, inventory, or manufacturing systems
• Strong communication skills and ability to support cross-functional teams

Work Environment

• Pharmaceutical manufacturing facility supporting sterile drug product production
• Cleanroom and controlled production areas (Grade A and Grade C)
• Weekend manufacturing schedule supporting critical production operations

WHO?

INCOG BioPharma Services is seeking an experienced and detail-oriented Deviation Writer to join our Manufacturing Engineering team. This role is crucial for translating a variety of complex technical events into clear, accurate, and robust investigations. The Deviation Writer will work closely with the Manufacturing, Production Engineering, Manufacturing Sciences and Technology, Supply Chain, Quality, and other cross-functional teams to create comprehensive investigations that leverage facts and data to support robust root cause conclusions, effective corrective actions, and systematic all-encompassing preventative actions. The Deviation Writer will exemplify excellent interpersonal skills and be capable of developing productive customer-centric working relationships with internal and external customers and have a role with high visibility to all departments. The Deviation Writer will have strong familiarity with industry standard electronic Quality Management System(s) and Microsoft Office suite products.

They will thrive working autonomously utilizing strong self-management and organization skills but also be able to interact, collaborate, and lead within a team environment. The Deviation Writer will value the processes owned by internal customers and subject matter experts and will possess a demonstrated ability to support and influence positive outcomes in the application of that knowledge to wider processes.

There is a growing need globally for more CDMOs (contract development and manufacturing organization) in the pharmaceutical industry to provide comprehensive services from drug development through drug manufacturing.

At INCOG, they are more than just a CDMO. A better way to create more meaningful experiences. A better way to create a culture that everyone can thrive and succeed in. At their core, that is who they are—a dedicated team that believes they can always be better.

Join the team at INCOG, a world-class CDMO for parenteral injectable drugs, shaping a new future for patients, for yourself, and for INCOG’s clients.

WHAT?

• Understand, investigate, and author a variety of deviating conditions or nonconforming events across multiple technical departments, in alignment with Subject Matter Experts.
• Self-motivated to fact gather, analyze information, interpret data, utilize expertise from Subject Matter Experts, etc. in an effort to provide supportive evidence to the investigation and root cause.
• Experience utilizing a variety of analysis tools to support root cause identification; Ishikawa Fishbone, 5 Why, etc.
• Ability to critically think outside the box for robust corrective and preventative actions; leveraging automation and engineering controls to error-proof equipment and processes.
• Demonstrated ability to translate complex, technical processes and descriptions into simplified, understandable write ups.
• Eagerness to collaborate and partner with both internal and external stakeholders to comprehensively represent the facts of an investigation in a logical and presentable manner.
• Evaluating historical deviating conditions, adverse events, non-conformances, etc. in order to identify and prevent trends.

YOU!

• Bachelor’s degree in a scientific, engineering, or technical discipline.
• Minimum of 3 years of experience in technical writing within a regulated GMP environment, preferably in the pharmaceutical, biopharmaceutical, or biotechnology industries.

Additional Preferences:

• Proficient in writing clear, concise, and accurate technical documentation.
• Strong understanding of GMP manufacturing processes and regulatory requirements.
• Excellent organizational skills with high attention to detail.
• Ability to collaborate effectively with cross-functional teams and communicate complex information to diverse audiences.
• Familiarity with documentation tools and electronic document management systems (EDMS).
• Exceptional computer skills, particularly moderate to expert level experience with Microsoft Word and Microsoft Excel.

Why INCOG?

• Paid time off, based on tenure
• 11 paid holidays
• 401(k) plan with company match up, vested immediately
• Choice of health & wellness plans
• FSA and HSA options
• Onsite wellness facility
• Employee engagement activities; food trucks, monthly luncheons, fundraising events, team building competitions, offsite celebrations

Don’t meet all the requirements? Don’t sweat! We’re always looking for an excuse to discuss your next opportunity. You might just surprise yourself…

Lead Candidate wholeheartedly supports Equality and Diversity in employment and opposes all forms of unlawful or unfair discrimination on the grounds of age, disability, sex, gender reassignment, sexual orientation, pregnancy and maternity, race, religion or belief and marriage and civil partnerships.

LHH is seeking a Production Manager for a Direct Hire, Permanent Placement position with a food/beverage manufacturing client located in the Greater Indianapolis, IN area. In this role, you will join a well-established organization who has a very positive reputation in the community and is well-known for manufacturing products at the highest level of quality. You will direct the production and operations teams, lead continuous improvement projects, implement change, manage P&L, and contribute to the growth of this facility and its employees. The compensation is commensurate to experience and will range between $120,000-135,000 per year plus bonus and includes several medical insurance options to choose from, generous Paid Time Off, and a 401K plan.

***Must be authorized to work in the U.S. without employer sponsorship.***

JOB RESPONSIBILITIES

• Responsible for the overall direction, coordination, and evaluation of all production operations across the manufacturing facility
• Review/revise standard operation procedures, prepare and maintain operations budget, and lead strategic planning meetings to ensure the achievement of company KPIs
• Oversee all special projects and capital projects
• Ensure all departments are operating effectively, encouraging collaboration, and adhering to quality and sanitation standards
• Develop strategies to increase productivity and reduce waste
• Focus on cost-effective initiatives to increase company profitability while maintaining high levels of customer service
• Analyze production metrics and data to determine areas to improve
• Foster a collaborative work culture through open communication, high visibility and strong leadership
• Be a proactive leader, self-motivated and able to analyze, react and develop a plan of action and see it through
• Be a team player, value people, and be able to work with diverse personalities and backgrounds
• Ensure the plant is adequately staffed and trained

NON-NEGOTIABLE QUALIFICATIONS

• Bachelor’s Degree in Business, Operations Management, Supply Chain Management, Engineering or a related field is highly preferred
• Minimum of 5+ years of experience at the Operations Manager and/or Plant Manager level with responsibility over a food/beverage manufacturing plant is required
• Must have 8+ years of experience within food/beverage manufacturing
• Must have experience with sanitation within a food/beverage manufacturing facility
• Previous experience and/or knowledge of GMP, HACCP, and SQF is preferred
• Strong business acumen and experience with strategic planning, budgeting, improving EBITDA, resource allocation, gross margin improvement, human resources, customer service, and leadership of direct reports
• Proven track record of implementing initiatives resulting in increased organizational efficiencies and profitable outcomes
• Ability to maintain positive relationships with customers, employees and fellow leadership, exemplifying professionalism and driving a culture of positivity and excellence

***Must be authorized to work in the U.S. without employer sponsorship.***

If you or someone in your network fit this profile and would like to apply for this Production Manager role located in the Greater Indianapolis, IN area, please submit your application alongside your resume using the link in this posting.

Equal Opportunity Employer/Veterans/Disabled

To read our Candidate Privacy Information Statement, which explains how we will use your information, please visit Company will consider qualified applicants with arrest and conviction records.

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ABOUT US

Envoy has been serving communities across the state of Indiana with high-end and community focused development and construction projects for the last 40+ years. We are a multifaceted company driven to enrich our communities and our team. We are a team of collaborative self-starters. We value commitment and transparency while standing by our family-like company culture.

JOB SNAPSHOT

The Pre-Construction Manager leads the planning and budgeting phases of assigned projects, guiding design teams through programmatic, schematic, design development, and construction documentation. This role requires strong professional communication and collaboration with municipal agencies, owners, developers, architects, designers, and subcontractors. The Pre-Construction Manager works to develop, update, and validate project budgets and historical cost data.

RESPONSIBILITIES

Preconstruction Planning & Budgeting

• Manage estimates, budget development, risk analysis, and client communication throughout all preconstruction phases.
• Prepare and refine quantity take-offs, cost estimates, and cost analyses in collaboration with the Chief Estimator.
• Ensure strict adherence to design parameters by obtaining and reviewing plans and related documentation.
• Maintain and update historical cost databases and project estimate records.
• Accurately present job costs, schedule updates, and budget adjustments at defined intervals.

Project Documentation & Procurement

• Assist with the preparation of RFQs/RFPs, scope-of-work packages, and bid documents.
• Upload, organize, and maintain bid documentation using internal and external procurement platforms.
• Support subcontractor buyout and award processes across multiple project delivery methods.
• Maintain and update master scope-of-work templates for all subcontract bid categories.

Coordination & Communication

• Lead internal team meetings, design progress discussions, and budget review sessions.
• Collaborate with owners/developers to secure required building permits and ensure compliance with local codes.
• Manage and facilitate value engineering and value-management sessions for all assigned projects.
• Work jointly with the Chief Estimator, architects, clients, and vendors to ensure clear communication and alignment.

Administrative & Financial Responsibilities

• Develop and manage preconstruction schedules.
• Oversee monthly billings and ensure compliance with cost procedures during preconstruction.
• Uphold and promote the company’s core values, contributing positively to organizational culture.

REQUIRED QUALIFICATIONS

• Bachelor’s Degree in Construction Management, Building Construction, Engineering, or a related discipline preferred, but not required.
• Minimum 3 years of experience in public/private commercial construction, development, or estimating.
• Estimating software: Destini, Planswift, Onscreen or other similar takeoff software.
• Project manager software: Procore or similar construction management software.
• Scheduling: MS Project and outbuild.
• Document Management & Collaboration: Google Workspace (Gmail, Drive, Sheets, Docs), PDF markup/annotation tools, Bluebeam Revu, word, and excel proficiency.
• Bid Management: Building Connected or similar procurement platforms.
• Proven ability to produce conceptual and schematic budgets ranging from $5M–$50M.
• Ability to prepare conceptual site and building phasing plans for presentations.
• Ability to understand project processes and standard progression for construction projects including document control.
• Strong fluency in reading plans, interpreting specifications, and navigating project documentation.
• Excellent written and verbal communication skills across diverse project teams.
• Effective dispute resolution skills with the ability to reach timely, mutually satisfactory outcomes.
• Highly organized, detail-oriented, and able to manage multiple time-sensitive tasks.
• Commitment to continuous learning and willingness to take on increasing responsibilities.
• Ability to work collaboratively with internal and external partners, including design teams and vendors.
• Must pass a criminal background check

COMPENSATION & BENEFITS

• Top-notch, competitive compensation packages that keep up with ever-changing markets.
• Company-sponsored retirement packages, available during the open enrollment period, after the completion of your first year.
• A flexible Paid Time Off program that focuses on family and mental health.

Start with a job, stay for a career.

For over 100 years, Edward Rose & Sons has been committed to career development for our team members. We offer you the opportunity to grow in an environment where you will feel valued, have room for advancement, and be rewarded for your good work.

We are currently looking for a Project Manager to join our team in Carmel, IN! The Project Manager will participate in the development and construction of multi-family unit projects, and handle the contracting, scheduling, budgeting, and implementation of each assigned project. The right candidate will plan, direct, and coordinate activities concerned with the construction of a project from inception to turnover.

What are the responsibilities of the Project Manager?

• Research and identify qualified trades and suppliers to bid on construction projects.
• Review plans for constructability and provide insight on value engineering.
• Write and negotiate contracts with suppliers and trades.
• Perform detailed analyses of bids and create spreadsheets for the Director of Construction to review.
• Write detailed lists for quantities of material usage if needed.
• Work cohesively with the General Superintendent to develop, monitor and publish construction schedules.
• Work directly with Superintendents to help resolve any construction issues on-site.
• Setup weekly jobsite meetings with Superintendents and their contractors to help facilitate workflow and to hold trades accountable for quality work and performance pursuant to the contracts.
• Understand compliance with building and safety codes and regulations.

Requirements:

• Bachelor’s degree in construction management or engineering is preferred.
• Extensive experience in multi-family or hospitality construction is required.
• Previous experience in a Superintendent role is preferred.
• Ability to write construction schedules using Excel or MS Project is required.
• Land development experience is a plus.
• Experience using Yardi Voyager or related property management software is a plus.
• The ability to work cooperatively with others.
• Must present the ability to execute job duties under stressful circumstances, such as last-minute deadlines or other difficult situations.
• Must be willing to fly to various locations via private or public air transportation

BENEFITS & COMPENSATION:

• Comprehensive benefits packages, including 401k plan with substantial company match
• Generous paid time off plan
• Competitive compensation program
• Opportunities for advancement
• Great working environment
• Generous discount on apartments

We are an Equal Opportunity Employer, and we affirmatively seek diversity in our workforce. We recruit qualified candidates and advance our employees without regard to race, color, religion, gender, age, disability, genetic information, ethnic or national origin, marital status, veteran status, or any other status or characteristic protected by federal, state or local laws.

Community Maintenance Landscape Manager

Primary Function:

The Community Maintenance and Landscape Manager (the “CMLM”) will be primarily

responsible for overseeing the aesthetics of all Old Town residential communities which

includes amenity and landscape planning and installation for new communities, repair and

upkeep of existing communities, and general oversite of the various property owners’

associations in partnership with our third-party management vendors. In collaboration with

the Project Executive over Land Development, the CMLM owns the fulfillment &

maintenance of the design aesthetic for each community Old Town develops.

Contribution to Company Mission and Vision:

The CMLM shall work collaboratively to ensure that the Company continues to create

communities that flourish, while supporting the foundational principles of pursuing

outstanding locations and timeless designs. The CMLM shall maintain the integrity of the

Old Town brand in all aspects of their position while contributing to the values of gratitude,

ownership, perseverance, accountability and innovation.

Role Absolutes:

1. Be involved in landscape design & Lead long-term landscape maintenance of

the community

2. Manage Builders

3. Own the release of Maintenance Bonds

Primary Responsibilities:

Work with the leadership team to participate in early land planning exercises to understand the

overall needs of the community and inform planning based on existing communities.

Accomplish the stated project objectives within the stipulated time of all assigned

projects.

Ensure that all project requirements are completed; at the same time ensure that quality,

cost and time are properly managed.

Document and store lot conditions through pictures.

Secure competitive bids and make award recommendations of responsive/responsible

contractors.

Supervise subcontractors for compliance with construction documents, quality

requirements and critical path schedule.

Review/approve payment of subcontractor pay applications and purchase orders

Supervise Grounds Maintenance Manager for successful pre and post lot inspections & on-going

community maintenance for the remaining life cycle of the development, post

construction turnover

Assist in developing accurate cost projections; scope, budget and schedule.

Monitor and coordinate the work effort of all consultants and subcontractors to ensure

their scope of work is in conformance with the project budget, schedule, and development

guidelines.

Schedule maintenance and repairs, regularly inspect property to ensure it is in good

working order, quickly resolve emergency maintenance issues in coordination with the

Grounds Maintenance Manager.

Keep open dialogue with Owners on vacancies, tenants, physical condition of property and

financial issues.

Maintain property by investigating and resolving complaints, completing repairs, and

contracting with landscaping and snow removal services.

Participate in HOA meetings in support of the Community Manager role.

Support the Community Manager role in accurate budget creation and adherence to

operating budgets.

Architecture Review Board – attend bi-weekly ARB meetings and coordinate architectural

approvals in partnership with legal administrator.

Serve on ARB providing detailed input on all builder plan submissions to the board.

Review homebuilder landscape plans for approval for each community that Old Town

manages and confirm installation per plan.

Manage all property owner maintenance issues that fall outside of the HOA property

management services agreement.

Maintain building systems by contracting for maintenance services and supervising repairs

for all Old Town owned properties not managed by third party services (HQ, Field Office,

future development sites).

Provide accurate documentation, reporting, and data collection to ensure compliance with

any financial reporting requirements.

Maintain maintenance logs and report on activities per property/community.

Ensure health and safety policies are in compliance.

Attend weekly/monthly/quarterly project meetings with agendas that include status

updates and tasks to be accomplished.

Other duties as assigned

Education and Experience:

• Minimum high school diploma or equivalent required.

• Valid, unrestricted driver’s license and good driving record required.

• Minimum 5 years in construction, development design and/or land & site

development.

• Must be able to read, understand and evaluate civil engineering, dry utility, and

landscape plans.

• Good written, oral, organizational and math skills.

• Must possess professional attitude to represent the company in a positive manner.

• Ability to perform multiple detail-oriented tasks with simultaneous deadlines in a

professional matter.

• Knowledge in Microsoft Office (Word, Excel) and Microsoft Project a plus.

• Excellent project management, organizational, time management, and planning

skills. Strong customer service skills are a plus.

Reporting:

The Community Maintenance and Landscape Manager will report directly to the Land

Development Project Executive.

OLD TOWN DESIGN GROUP

ESTIMATOR JOB DESCRIPTION

Old Town Design Group is seeking an Estimator to join our team in Carmel, IN. We are a dynamic and growing custom home builder, known for developing outstanding locations with timeless home designs. Old Town has a passion for people and the communities in which we work, and we are looking for a like-minded team member who will bring a passion for excellence, great work ethic, and a positive, can-do attitude to our team.

FUNCTION

The Estimator serves as a vital function in the growth of Old Town Design Group. The Estimator will be responsible for preparing accurate cost estimates for single family detached and attached construction projects; calculate and process Change Orders; solicit and obtain bids and proposals; facilitate cost management; produce and distribute budgets for purchasing; and, work independently and cross departmentally to reduce costs without negatively impacting quality or timeliness of construction. This is a challenging position that will require strong attention to detail, as well as the ability to work well under pressure when facing bid deadlines.

MISSION

The Estimator will maintain the integrity of Old Town in all aspects. All responsibilities performed require extensive knowledge and understanding of all Old Town residential and commercial properties, mission and values. Candidate will possess an entrepreneurial work ethic and be able to work collaboratively with other Old Town team members.

RESPONSIBILITIES

• Prepare cost estimates for single family detached and attached construction projects with high levels of accuracy and in a timely manner
• Solicit and obtain bids and proposals from vendors and subcontractors utilizing detailed RFQ’s
• Assist with source selection and communication of awarded contracts
• Coordinate cost estimates and budgets with Sales and Construction team as required
• Calculate and process Change Order requests on active projects per company procedures and established timelines
• Facilitate cost management and tracking of all produced estimates
• Produce and distribute accurate budget information to Purchasing per required company timelines
• Perform Gross Margin analysis on completion of each project and make corrective action to estimating means and methods as required to improve accuracy and eliminate process inconsistencies
• Work cross departmentally and with vendors and subcontractors to identify cost savings opportunities that eliminate waste or inefficiency but do not negatively impact quality or timeliness; implement as required
• Other duties as assigned

EDUCATION AND EXPERIENCE REQUIRED

• Bachelor’s Degree in Construction Management, Engineering, or related field or 1+ years of residential or commercial construction estimating experience
• Strong knowledge of construction practices and constraints
• Knowledge of construction purchasing and receiving process preferred
• Knowledge of Value Engineering and Lean Construction practices preferred

SKILLS AND COMPETENCIES REQUIRED

• Experience with Microsoft Excel, AutoCAD, BlueBeam, SoftPlan, or related software
• Strong ability to listen, interpret, evaluate and perform all communication internally and externally
• Ability to use logic, reasoning, considering alternatives and relative costs when applying estimating practices
• Ability to identify problems and inefficiencies, working with others to implement potential actions
• Willingness to participate in continuing education and learning opportunities as needed to excel in the position

OCCUPATIONAL SAFETY AND WORKPLACE COMPLIANCE

• Compliance with workplace policies and procedures for risk identification, risk assessment and risk control.
• Active participation in activities associated with the management of workplace health and safety
• Identification and reporting of health and safety risks, accidents, incidents, injuries and property damage at the workplace
• Correct utilization of appropriate personal protective equipment

They will maintain the integrity of the Old Town brand by contributing to the values of gratitude, ownership, perseverance, adaptability, and innovation.

Senior Consultant / Manager – Supply Chain Design

Fishers, IN (Hybrid: 3 days in office, 2 remote)

We are seeking an experienced Senior Consultant / Manager to lead complex supply chain design and transformation projects. This role combines advanced analytics, executive-level advisory, and team leadership to deliver measurable business impact.

You’ll serve as a trusted advisor to VP and C-suite stakeholders, translating complex data into actionable strategies while mentoring high-performing consulting teams.

What We’re Looking For

• Bachelor’s or Master’s degree in Engineering, Supply Chain, Operations Research, or related field
• 8+ years of experience in supply chain design, optimization, or analytics
• Proven success leading consulting engagements and managing stakeholders
• Experience with large-scale supply chain transformation initiatives
• Strong modeling expertise (Coupa/LLamasoft, AIMMS, RiverLogic)
• Proficiency in Python or SQL; familiarity with Gurobi/CPLEX a plus
• Experience with Power BI or Tableau
• Strong executive presence and communication skills

What’s Offered

• High-visibility leadership role in a growing market
• Ownership of transformative, large-scale projects
• Comprehensive benefits including medical, dental, vision, 401(k), and PTO
• Global exposure and professional development opportunities
• Collaborative, performance-driven culture

This is an excellent opportunity for a strategic supply chain leader who thrives in a consulting environment and enjoys driving data-driven transformation at scale.

Production Engineer

WHO?

The Production Engineer is a key technical role within INCOG BioPharma Engineering and Technical Operations to ensure data integrity, implement state-of-the-art digital technologies, process control strategies, and support the technology road map.

The ideal candidate must have experience in pharmaceuticals and/or biologics, GMP manufacturing, and/or within highly regulated industries as well as knowledge and experience in aseptic filling, sterile manufacturing, and engineering principles.

This is a 2nd shift position.

WHAT?

• Resolve issues that arise per daily operation and provide timely responses and solutions
• Implement solutions in collaboration with cross-functional technical teams and site leadership
• SME for filling equipment and supporting systems
• Evaluate and improve efficiency of manufacturing instruments, equipment, and tools
• Evaluate and implement new changes
• Participate and/or support process FMEAs to understand process and product risks as a pre-requisite for process validation.
• Provide technical support to manufacturing activities
• Apply Good Engineering Practices (GEP) to drive site engineering and operational excellence.
• Partner with vendors and suppliers to define requirements and understand functional specifications
• Work flexible hours to ensure production facility coverage

YOU!

• Bachelor’s degree in engineering field or life sciences with 5+ years of relevant work experience
• Demonstrated knowledge of pharmaceutical manufacturing of biotechnology products, aseptic processing (fill and finish), and process development
• Hands-on experience troubleshooting, repairing and performing preventative maintenance of manufacturing equipment

Additional Preferences:

• Lean Six Sigma Certification
• Practical expertise with cGMP manufacturing and regulatory requirements for pharmaceuticals and devices
• Applicable experience with process design, data integrity, controls, instrumentation, and electro-mechanical systems

Why INCOG?

• Paid time off, based on tenure
• 11 paid holidays
• 401(k) plan with company match up, vested immediately
• Choice of health & wellness plans
• FSA and HSA options
• Onsite wellness facility
• Employee engagement activities; food trucks, monthly luncheons, fundraising events, team building competitions, offsite celebrations

Don’t meet all the requirements? Don’t sweat! We’re always looking for an excuse to discuss your next opportunity. You might just surprise yourself…

Lead Candidate wholeheartedly supports Equality and Diversity in employment and opposes all forms of unlawful or unfair discrimination on the grounds of age, disability, sex, gender reassignment, sexual orientation, pregnancy and maternity, race, religion or belief and marriage and civil partnerships.