Engineering Jobs in Westfield In Flexible

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

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

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.