Jobs · Management · Indiana

OPEX Process Specialist

Simtra BioPharma Solutions · Bloomington, IN · 1 mo ago
On-siteManagementFull-time
We need to output HTML fragment with sections: About the role? Actually we have description of company and role. The instruction: Use

for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). Do NOT repeat the job title as a heading. Do NOT put Job ID / requisition numbers as headings — fold minor metadata into a short

or drop it. Preserve ALL substantive information; do NOT invent or summarize away detail. Remove cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate, duplicated lines, and application instructions. IMPORTANT: include a section ONLY when the posting has real, specific content for it — never emit a heading followed by filler/placeholder text (e.g. "commensurate with experience", "not specified", "N/A", "varies", "TBD") and never create Pay/Schedule/Benefits sections unless the posting actually states them. Prefer a few substantive sections over many thin ones. We need to decide which sections to include based on content. We have: - Company description (Simtra BioPharma Solutions) – could be "About the role"? Actually "About the role" is generic heading for description of role. Could also be "About the company". But they gave examples: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. We have responsibilities list. We have required qualifications. We have physical/safety requirements (maybe part of Requirements). We have benefits list. No explicit Pay or Schedule (though schedule: "This position is 100% onsite at the Bloomington location." That's location, not schedule. No mention of work hours, shift, etc. So we should not create Schedule section because no specific schedule info. Pay not mentioned, so omit. We have "Why join Team Simtra?" with values – could be part of About the role or maybe "Benefits"? But they already have benefits list. The "Why join Team Simtra?" is more about culture/values. Could be part of About the role description. We have "Physical / safety requirements:" – could be part of Requirements or Qualifications. We have "In return, you’ll be eligible for[1]:" then benefits list. Thus sections: - About the role (maybe include company overview and role description) - Responsibilities - Requirements (or Qualifications) – we have both "Required qualifications:" and "Physical / safety requirements:" maybe combine into Requirements. - Benefits We should not create Skills section separately unless we have explicit skills list. We have "Excellent problem-solving skills", "Excellent oral and written communication skills", "Intermediate proficiency in Microsoft Office Suite", "Six Sigma Green Belt certification or higher preferred". Those could be under Skills or Qualifications. But we can incorporate them into Requirements/Qualifications. We need to avoid filler headings. So we will include:

About the role

with paragraph(s) containing company description and role overview.

Responsibilities

with
  • list.

    Requirements

    with
    • list (including required qualifications, physical/safety requirements, maybe also skills).

      Benefits

      with
      • list. We must not include Pay or Schedule. We must preserve all substantive information: need to include details like location (100% onsite at Bloomington), reporting lines, etc. Also include the "Why join Team Simtra?" values. We need to remove boilerplate: Disclaimer, Equal Employment Opportunity, Data Privacy, etc. Also remove duplicated lines. Let's extract substantive content: Company description paragraph: "Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization. Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide. As such, there is a strong emphasis on quality and continuous improvement at Simtra. We hold ourselves to the highest quality and regulatory standards. While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging. Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide." Then "Why join Team Simtra? Because we: Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers. Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways. Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members. Make it COUNT – We take pride in our day-to-day work, knowing the impact we make – taking on challenges big and small to improve patient health." Then "This role: The OPEX (Operational Execution) Process Specialist provides technical/process support to maximize production efficiency. The position is visible on the manufacturing floor and has high interaction with the production team. It’s expected that the OPEX Process Specialist will drive process improvements and equipment effectiveness (equipment availability, operator efficiency and product yield). This position reports directly to the Associate Director of OPEX and indirectly to production management. This position is 100% onsite at the Bloomington location." Then responsibilities bullet list (starting with "The responsibilities:" then list). Let's capture each bullet: - Evolve into a SME (subject matter expert) for assigned manufacturing processes/equipment - including, but not limited to, syringe/vial lines (value stream), lyophilizers, isolators, and packaging equipment - Serve as advisor to building leadership, relative to assigned equipment and processes - Use Lean/Six Sigma tools (SPC, CPk, Statistics, Pareto, Fishbone, 5-Why’s, etc.) to drive improvements in overall equipment effectiveness (OEE) - Participate and lead cross-functional continuous improvement initiatives (Kaizens) impacting performance and conversion loss - Manage multiple projects and work with cross-functional teams - Responsible for standardization/training of set-up, operating, and troubleshooting procedures for production, maintenance, and training personnel - Ability to create, manage and approve master change controls and work orders - Participate in and/or author investigation/analysis of complex issues and determine root cause(s) and implement innovative, cost-effective corrective actions to prevent recurrence Then "Required qualifications:" list: - BS degree in science or technology preferred or 5+ years of pharmaceutical manufacturing experience in lieu of a BS degree - 3+ years experience in a regulated industry/environment - Intermediate proficiency in Microsoft Office Suite (Word, Excel, and Outlook) - Excellent problem-solving skills with ability to provide solutions - Excellent oral and written communication skills - Six Sigma Green Belt certification or higher preferred Then "Physical / safety requirements:" list: - Duties may require overtime work, including nights and weekends - Extended periods of standing and/or walking - Extended periods in Grade C/D production environments Then benefits list after "In return, you’ll be eligible for[1]:" (the footnote reference). Benefits: - Day One Benefits - Medical & Dental Coverage - Flexible Spending Accounts - Life and AD&D Insurance - Supplemental Life Insurance - Spouse Life Insurance - Child Life Insurance - 401(k) Retirement Savings Plan with Company Match - Time Off Program - Paid Holidays - Paid Time Off - Paid Parental Leave and more - Adoption Reimbursement Program - Education Assistance Program - Employee Assistance Program - Community and Volunteer Service Program - Employee Ownership Plan - Additional Benefits - Short and Long-Term Disability Insurance - Voluntary Insurance Benefits - Vision Coverage - Accident - Critical Illness - Hospital Indemnity Insurance - Identity Theft Protection - Legal and more - Onsite Campus Amenities - Workout Facility - Cafeteria - Credit Union Also footnote: "[1] Current benefit offerings are in effect through 12/31/26". That's substantive; we should include maybe as a note after benefits. We need to avoid duplication: "Day One Benefits" maybe a heading but it's a bullet; we keep as bullet. Now produce HTML. We need to wrap sections in

        and then content. For About the role: combine company description, why join, role overview. Could be multiple paragraphs. We'll output:

        About the role

        Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization. Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide. As such, there is a strong emphasis on quality and continuous improvement at Simtra. We hold ourselves to the highest quality and regulatory standards. While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging. Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.

        Why join Team Simtra? Because we: Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers. Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways. Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members. Make it COUNT – We take pride in our day-to-day work, knowing the impact we make – taking on challenges big and small to improve patient health.

        This role: The OPEX (Operational Execution) Process Specialist provides technical/process support to maximize production efficiency. The position is visible on the manufacturing floor and has high interaction with the production team. It’s expected that the OPEX Process Specialist will drive process improvements and equipment effectiveness (equipment availability, operator efficiency and product yield). This position reports directly to the Associate Director of OPEX and indirectly to production management. This position is 100% onsite at the Bloomington location.

        Then Responsibilities:

        Responsibilities

        • Evolve into a SME (subject matter expert) for assigned manufacturing processes/equipment - including, but not limited to, syringe/vial lines (value stream), lyophilizers, isolators, and packaging equipment
        • Serve as advisor to building leadership, relative to assigned equipment and processes
        • Use Lean/Six Sigma tools (SPC, CPk, Statistics, Pareto, Fishbone, 5-Why’s, etc.) to drive improvements in overall equipment effectiveness (OEE)
        • Participate and lead cross-functional continuous improvement initiatives (Kaizens) impacting performance and conversion loss
        • Manage multiple projects and work with cross-functional teams
        • Responsible for standardization/training of set-up, operating, and troubleshooting procedures for production, maintenance, and training personnel
        • Ability to create, manage and approve master change controls and work orders
        • Participate in and

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